Dr. Steven R. Bauer

Family Medicine / Anti-Aging Medicine & Clinical Research located in Charlotte, NC

About Dr. Steven R. Bauer

Dr. Steven R. Bauer is the founder and a managing partner of Ballantyne Medical Associates in Charlotte, North Carolina, where he has been practicing since March 2007. His dedication to helping his patients achieve their optimal health is evident in his focus on treating the whole person and keeping in mind the multiple aspects of each of their individual lives.

He graduated cum laude from the department of agriculture and life science in the pre-med program at North Carolina State University. Dr. Bauer then entered the medical school campus of the New York Institute of Technology. After graduating medical school with honors he completed his internship and residency programs at Good Samaritan Hospital Medical Center in New York. Dr. Bauer was then elected to serve as chief resident to complete his final year of training at Good Samaritan. After residency, he went on to become national board-certified in family medicine and osteopathic medicine. Prior to moving to NC in December 2006, he spent nine years in private practice in NY while also working as a Suffolk County New York Department of Health HIV disease specialist in a hospital-operated county clinic. Currently, he is completing a fellowship in anti-aging and regenerative medicine with the Metabolic Medicine Institute - American Academy of Anti-Aging Medicine(A4M).

Dr. Bauer has a passion for medical research and helping bring new pharmaceutical products to market. These new, cutting-edge pharmaceuticals are used by our nation's physicians to help their patients live longer and healthier lives.

He is certified by the Collaborative Institutional Training Initiative ( CITI ) to conduct Human Clinical Research.  As a Principal Investigator for numerous pharmaceutical companies, he conducts research on many new investigational medications. Dr. Bauer has been instrumental in bringing many new drugs to market and FDA product label changes for new indications of current medications. 

Dr. Bauer is also certified through (ACT) Aesthetic Consulting & Training to administer Botox Cosmetic injections to help both his male and female patients maintain a more youthful appearance. He states "It's more than just a physical change my patients' experience, they also have a renewed confidence and possess a more positive and healthy outlook."

Dr. Bauer is also certified by Massachusetts based Cynosure in the use of SculpSure, ICON, PicoSure, Pelleve and Pellefirm laser and light-based cosmetic procedures.

He is a founding and current board member of Independent Physicians of the Carolina’s (IPC), a member of the North Carolina Medical Society (NCMS), American College of Osteopathic Family Physicians (ACOFP), American Academy of Anti Aging Medicine (A4M), American Academy of HIV Medicine (AAHIVM), Concierge Choice Physicians (CCP) and he is the lead physician to the 10-13 (officer down) Club of Charlotte which encompasses hundreds of retired and active police officers.

 

Clinical Trials conducted by Dr. Bauer as P.I. ( Principle Investigator )

 

ADHD (Attention-Deficit/Hyperactivity Disorder):

Otsuka, 405-201-00017, A Phase 3, multicenter, open-label, long-term trial evaluating the long-term safety and tolerability of once-daily centanafadine capsules in children and adolescents with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00015, A Phase 3, open-label, 52-week, multicenter trial evaluating the long-term safety and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00014, A Phase 3, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial evaluating the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (trial 405-201-00014)

 

Asthma:

AstraZeneca, D5982C00007, A Phase 3, randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 weeks variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate MDI and Symbicort® Pressurized MDI in Adult and adolescent participants  with inadequately controlled asthma (KALOS)

Cipla, U-FS-MU-AS3120, A phase 4 multicenter, randomized, parallel-group, placebo-controlled, 4-week clinical endpoint bioequivalence study comparing fluticasone propionate/salmeterol 100/50 mcg inhalation powder (Cipla Ltd. India) with Advair® Diskus 100/50 mcg (GlaxoSmithKline, USA) in asthma patients

Bond Avillion 2, AV003, A Phase 3 Long-term, randomized, double-blind, multicenter, parallel group, evaluating the efficacy and safety of PT027 compared to PT007 administered as needed in response to symptoms in symptomatic adults and children 4 years of age or older with asthma

 

Cancer:

Clinlogic Research, CGx-02252019 , A study to evaluate the clinical benefit of using hereditary cancer genome diagnostics to assess overall hereditary genetic cancer risk profile to help guide physicians to pursue preventative measures which may lead to early detection and treatment of the cancer condition

 

Chlamydia:

Evofem Biosciences, EVO100-311, A Phase 3 double-blind placebo-controlled efficacy trial EVO100 vaginal gel for the prevention of urogenital chlamydia trachomatis and neisseria gonorrhea (EVOGUARD)

 

COPD (Chronic Obstructive Pulmonary Disease):

Sanofi Aventis EFC15805, A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 52- week pivotal study to assess the efficacy, safety, and tolerability of dupilumab in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation

Boehringer Ingelheim 1237-0064 The AIRWISE study, assessment in a real world setting of the effect of inhaled steroid-based triple therapy versus the combination of tiotropium and olodaterol on reducing COPD exacerbations

AstraZeneca, D3251C00004 A Phase 3, randomized, double-blind, double dummy, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase iii study to evaluate the efficacy and safety of 3 doses of benralizumab (medi-563) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) with a history of COPD exacerbations (terranova)

 

COVID-19:

AstraZeneca, D8851C00001 A Phase 3, randomized, double-blind, placebo controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

AstraZeneca, D8851C00001, unblinded A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

Sorrento Therapeutics, AMG-COV-201, A Phase 2, randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, and efficacy of a single dose of STI-202 (COVI-AMG) in outpatient adults with COVID-19

Revive, RT-003, A Phase 3 multi-center, randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 (ARISE)

Cytomegalovirus:

Moderna, CMV mRNA-1647-P301, A Phase 3, randomized, observer-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1647 Cytomegalovirus (CMV) vaccine in healthy females 16 to 40 years of age

 

Diabetes:

Novo Nordisk, NN9924-4668, A study of patients with onset of type 2 diabetes (T2D) at a young age is a high-risk population with need for intensified therapy

Novo Nordisk, NN1436-4383, A Phase 2, investigational trial comparing the efficacy and safety of once weekly nnc0148-0287 c (insulin 287) versus once daily insulin glargine, both in combination with metformin, with or without dpp-4 inhibitors, in insulin native subjects with type 2 diabetes mellitus

Novo Nordisk, NN9924-4558, (Realyse) A long term comparative effectiveness of once daily semaglutide versus any other oral glucose lowering medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk NN9535-4416, A Phase 4 long term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

Novo Nordisk, NN1250-4252, A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without an oral antidiabetic drug

Novo Nordisk, NN2211-4315 , A study of LIRA-ADD2SGLT2i - liraglutide versus placebo as add-on to SGLT2 inhibitors

Novo Nordisk, NN2211-4232, A study of the efficacy in controlling glycemia with Victoza® (liraglutide) as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes inadequately controlled with metformin monotherapy and treated in a primary care setting

Novo Nordisk, NN9924-4233, A study of the efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise 

Novo Nordisk, NN9924-4222, A study of the efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes

Novo Nordisk, NN1250-3998, A randomized, double blind cross over trial comparing the safety and efficacy of insulin degludec and insulin glargine, with or without OADs in subjects with type 2 diabetes

Novo Nordisk, NN9535-3623, A study of the efficacy and safety of semaglutide once weekly versus placebo in drug-naive subjects with type 2 diabetes

 

Gout:

LG Chem, LG-GDCL002, A Phase 2, randomized, multicenter, double-blind, parallel-group, placebo-controlled, dose finding study to assess the efficacy and safety of LC350189 in gout patients with hyperuricemia

 

Hot Flashes:

Astellas, 2693-CL-0304, A Phase 3, randomized, placebo-controlled, double-blind clinical study to investigate the long-term safety of Fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301, A Phase 3, randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

 

Hypogonadism:

AbbVie, M19-161, A Phase 4, 24-hour ambulatory randomized blood pressure monitoring study in hypogondal men receiving testosterone replacement therapy

 

IBS (Irritable Bowel Syndrome):

OrphaMed, Inc., OM-201,, A Phase 2, double-blind, placebo-controlled, responsive adaptive randomization study of ORP-101 in patients with irritable bowel syndrome with diarrhea (IBS-D)

Synergy Pharmaceuticals, SP304203-06,, an open-label, long-term safety and tolerability study of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304203-04,, a randomized, 12-week, double-blind, placebo-controlled study of the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304-20212, a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study to assess the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

 

Influenza:

Roche Genentech, CV43551, A Phase 3, multicenter, single-arm, open-label study of direct transmission of influenza from otherwise healthy pediatric index patients treated with Baloxavir Marboxil to household contacts

Hoffman - La Roche MV40618, A Phase 3B, multicenter, randomized, double-blind, placebo controlled, clinical efficacy study of Baloxavir Marboxil for the reduction of direct transmission of influenza from otherwise healthy patients to household contacts

Emergo Therapeutics NKT-202, A Phase 2B, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy and safety of Norketotifen in the treatment of acute uncompromised influenza-like illness

Genentech was F. Hoffman-La Roche Ltd., CP40563 A multicenter, randomized, double-blind, active (Oseltamivir)-controlled study to assess the safety, pharmacokinetics, and efficacy of Baloxavir Marboxil in otherwise healthy pediatric patients 1 to <12 years of age with influenza-like symptoms

Janseen, 63623872FLZ3002, A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of pimodivir in combination with the standard of care treatment in adolescent, adult, and elderly non-hospitalized subjects with influenza A infection who are at risk of developing complications

Shionogi, 1601T0831, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in otherwise healthy patients with influenza

Shionogi, 1602T0832, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in patients with influenza at high risk for influenza complications

 

Menopause:

Astellas, 2693-CL-0304 A Randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301 A Phase 3, randomized, placebo-controlled, 12-week double-blind study, followed by a non-controlled extension treatment period, to assess the efficacy and safety of fezolinetant in women suffering from moderate to severe vasomotor symptoms (hot flashes) associated with menopause

 

Migraine:

Amgen, 20190008, A phase 4 comprehensive assessment of Erenumab efficacy in subjects with high frequency episodic migraine with at least 1 previously failed preventative treatment: a global, double-blind, placebo-controlled phase 4 study

Amgen, 20190389, Phase 4, open-label study to evaluate treatment satisfaction with Erenumab in patients with migraine

Teva, TV48125-MH-50039, A long-term, phase 4 study prospective, observational study to evaluate the safety, including cardiovascular safety, of Fremanezumab in patients with migraine in routine clinical practice, non-interventional

Satsuma, STS101-007, A randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of (Dihydroergotamine Nasal Powder) in the acute treatment of migraine

Amgen, 20170703, A Phase 4 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Erenumab in adults with chronic migraine and medication overuse headache

Biohaven, BHV3000-311, Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents >6 to <18 years of age

Impax Labs, IPX229-B16-01, A Phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy and safety of zolmitriptan nasal spray for the treatment of acute migraine in subjects ages 6 to 11 years, with an open-label extension

Evidera, Amgen, A-16821-000-20150133, A prospective observational study to evaluate tolerability and outcomes of prophylactic therapies in migraine

 

Obesity:

Novo Nordisk, NN9924-4558, (Realyse) A long-term comparative effectiveness of once daily semaglutide versus any other oral glucose lower medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk, NN9535-4416, A Phase 4 long-term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

 

Opioid Misuse:

Orexo, OXD01-001, A Phase 3, randomized open-label, parallel-group study to evaluate the efficacy of the digital therapeutic OXD01 (MODIA™) in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder

 

RSV (Respiratory Syncytial Virus):

Janssen, 53718678RSV2004A, A Pilot Phase 2, A randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 at two dose levels in non-hospitalized adult subjects infected with respiratory syncytial virus. 

 

Sickle cell:

Evidera Amgen, RBSC0161, Sickle Cell Disease (SCD) Patient-Reported Outcomes (PRO) Assessment

 

Testosterone Replacement:

AbbVie, M16-100, Phase 4, study on testosterone replacement therapy for assessment of long-term vascular events and efficacy in response in hypogonadal men

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Ballantyne Medical Associates

Dr. Steven R. Bauer is the founder and a managing partner of Ballantyne Medical Associates in Charlotte, North Carolina, where he has been practicing since March 2007. His dedication to helping his patients achieve their optimal health is evident in his focus on treating the whole person and keeping in mind the multiple aspects of each of their individual lives.

He graduated cum laude from the department of agriculture and life science in the pre-med program at North Carolina State University. Dr. Bauer then entered the medical school campus of the New York Institute of Technology. After graduating medical school with honors he completed his internship and residency programs at Good Samaritan Hospital Medical Center in New York. Dr. Bauer was then elected to serve as chief resident to complete his final year of training at Good Samaritan. After residency, he went on to become national board-certified in family medicine and osteopathic medicine. Prior to moving to NC in December 2006, he spent nine years in private practice in NY while also working as a Suffolk County New York Department of Health HIV disease specialist in a hospital-operated county clinic. Currently, he is completing a fellowship in anti-aging and regenerative medicine with the Metabolic Medicine Institute - American Academy of Anti-Aging Medicine(A4M).

Dr. Bauer has a passion for medical research and helping bring new pharmaceutical products to market. These new, cutting-edge pharmaceuticals are used by our nation's physicians to help their patients live longer and healthier lives.

He is certified by the Collaborative Institutional Training Initiative ( CITI ) to conduct Human Clinical Research.  As a Principal Investigator for numerous pharmaceutical companies, he conducts research on many new investigational medications. Dr. Bauer has been instrumental in bringing many new drugs to market and FDA product label changes for new indications of current medications. 

Dr. Bauer is also certified through (ACT) Aesthetic Consulting & Training to administer Botox Cosmetic injections to help both his male and female patients maintain a more youthful appearance. He states "It's more than just a physical change my patients' experience, they also have a renewed confidence and possess a more positive and healthy outlook."

Dr. Bauer is also certified by Massachusetts based Cynosure in the use of SculpSure, ICON, PicoSure, Pelleve and Pellefirm laser and light-based cosmetic procedures.

He is a founding and current board member of Independent Physicians of the Carolina’s (IPC), a member of the North Carolina Medical Society (NCMS), American College of Osteopathic Family Physicians (ACOFP), American Academy of Anti Aging Medicine (A4M), American Academy of HIV Medicine (AAHIVM), Concierge Choice Physicians (CCP) and he is the lead physician to the 10-13 (officer down) Club of Charlotte which encompasses hundreds of retired and active police officers.

 

Clinical Trials conducted by Dr. Bauer as P.I. ( Principle Investigator )

 

ADHD (Attention-Deficit/Hyperactivity Disorder):

Otsuka, 405-201-00017, A Phase 3, multicenter, open-label, long-term trial evaluating the long-term safety and tolerability of once-daily centanafadine capsules in children and adolescents with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00015, A Phase 3, open-label, 52-week, multicenter trial evaluating the long-term safety and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00014, A Phase 3, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial evaluating the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (trial 405-201-00014)

 

Asthma:

AstraZeneca, D5982C00007, A Phase 3, randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 weeks variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate MDI and Symbicort® Pressurized MDI in Adult and adolescent participants  with inadequately controlled asthma (KALOS)

Cipla, U-FS-MU-AS3120, A phase 4 multicenter, randomized, parallel-group, placebo-controlled, 4-week clinical endpoint bioequivalence study comparing fluticasone propionate/salmeterol 100/50 mcg inhalation powder (Cipla Ltd. India) with Advair® Diskus 100/50 mcg (GlaxoSmithKline, USA) in asthma patients

Bond Avillion 2, AV003, A Phase 3 Long-term, randomized, double-blind, multicenter, parallel group, evaluating the efficacy and safety of PT027 compared to PT007 administered as needed in response to symptoms in symptomatic adults and children 4 years of age or older with asthma

 

Cancer:

Clinlogic Research, CGx-02252019 , A study to evaluate the clinical benefit of using hereditary cancer genome diagnostics to assess overall hereditary genetic cancer risk profile to help guide physicians to pursue preventative measures which may lead to early detection and treatment of the cancer condition

 

Chlamydia:

Evofem Biosciences, EVO100-311, A Phase 3 double-blind placebo-controlled efficacy trial EVO100 vaginal gel for the prevention of urogenital chlamydia trachomatis and neisseria gonorrhea (EVOGUARD)

 

COPD (Chronic Obstructive Pulmonary Disease):

Sanofi Aventis EFC15805, A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 52- week pivotal study to assess the efficacy, safety, and tolerability of dupilumab in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation

Boehringer Ingelheim 1237-0064 The AIRWISE study, assessment in a real world setting of the effect of inhaled steroid-based triple therapy versus the combination of tiotropium and olodaterol on reducing COPD exacerbations

AstraZeneca, D3251C00004 A Phase 3, randomized, double-blind, double dummy, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase iii study to evaluate the efficacy and safety of 3 doses of benralizumab (medi-563) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) with a history of COPD exacerbations (terranova)

 

COVID-19:

AstraZeneca, D8851C00001 A Phase 3, randomized, double-blind, placebo controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

AstraZeneca, D8851C00001, unblinded A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

Sorrento Therapeutics, AMG-COV-201, A Phase 2, randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, and efficacy of a single dose of STI-202 (COVI-AMG) in outpatient adults with COVID-19

Revive, RT-003, A Phase 3 multi-center, randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 (ARISE)

Cytomegalovirus:

Moderna, CMV mRNA-1647-P301, A Phase 3, randomized, observer-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1647 Cytomegalovirus (CMV) vaccine in healthy females 16 to 40 years of age

 

Diabetes:

Novo Nordisk, NN9924-4668, A study of patients with onset of type 2 diabetes (T2D) at a young age is a high-risk population with need for intensified therapy

Novo Nordisk, NN1436-4383, A Phase 2, investigational trial comparing the efficacy and safety of once weekly nnc0148-0287 c (insulin 287) versus once daily insulin glargine, both in combination with metformin, with or without dpp-4 inhibitors, in insulin native subjects with type 2 diabetes mellitus

Novo Nordisk, NN9924-4558, (Realyse) A long term comparative effectiveness of once daily semaglutide versus any other oral glucose lowering medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk NN9535-4416, A Phase 4 long term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

Novo Nordisk, NN1250-4252, A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without an oral antidiabetic drug

Novo Nordisk, NN2211-4315 , A study of LIRA-ADD2SGLT2i - liraglutide versus placebo as add-on to SGLT2 inhibitors

Novo Nordisk, NN2211-4232, A study of the efficacy in controlling glycemia with Victoza® (liraglutide) as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes inadequately controlled with metformin monotherapy and treated in a primary care setting

Novo Nordisk, NN9924-4233, A study of the efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise 

Novo Nordisk, NN9924-4222, A study of the efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes

Novo Nordisk, NN1250-3998, A randomized, double blind cross over trial comparing the safety and efficacy of insulin degludec and insulin glargine, with or without OADs in subjects with type 2 diabetes

Novo Nordisk, NN9535-3623, A study of the efficacy and safety of semaglutide once weekly versus placebo in drug-naive subjects with type 2 diabetes

 

Gout:

LG Chem, LG-GDCL002, A Phase 2, randomized, multicenter, double-blind, parallel-group, placebo-controlled, dose finding study to assess the efficacy and safety of LC350189 in gout patients with hyperuricemia

 

Hot Flashes:

Astellas, 2693-CL-0304, A Phase 3, randomized, placebo-controlled, double-blind clinical study to investigate the long-term safety of Fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301, A Phase 3, randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

 

Hypogonadism:

AbbVie, M19-161, A Phase 4, 24-hour ambulatory randomized blood pressure monitoring study in hypogondal men receiving testosterone replacement therapy

 

IBS (Irritable Bowel Syndrome):

OrphaMed, Inc., OM-201,, A Phase 2, double-blind, placebo-controlled, responsive adaptive randomization study of ORP-101 in patients with irritable bowel syndrome with diarrhea (IBS-D)

Synergy Pharmaceuticals, SP304203-06,, an open-label, long-term safety and tolerability study of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304203-04,, a randomized, 12-week, double-blind, placebo-controlled study of the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304-20212, a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study to assess the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

 

Influenza:

Roche Genentech, CV43551, A Phase 3, multicenter, single-arm, open-label study of direct transmission of influenza from otherwise healthy pediatric index patients treated with Baloxavir Marboxil to household contacts

Hoffman - La Roche MV40618, A Phase 3B, multicenter, randomized, double-blind, placebo controlled, clinical efficacy study of Baloxavir Marboxil for the reduction of direct transmission of influenza from otherwise healthy patients to household contacts

Emergo Therapeutics NKT-202, A Phase 2B, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy and safety of Norketotifen in the treatment of acute uncompromised influenza-like illness

Genentech was F. Hoffman-La Roche Ltd., CP40563 A multicenter, randomized, double-blind, active (Oseltamivir)-controlled study to assess the safety, pharmacokinetics, and efficacy of Baloxavir Marboxil in otherwise healthy pediatric patients 1 to <12 years of age with influenza-like symptoms

Janseen, 63623872FLZ3002, A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of pimodivir in combination with the standard of care treatment in adolescent, adult, and elderly non-hospitalized subjects with influenza A infection who are at risk of developing complications

Shionogi, 1601T0831, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in otherwise healthy patients with influenza

Shionogi, 1602T0832, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in patients with influenza at high risk for influenza complications

 

Menopause:

Astellas, 2693-CL-0304 A Randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301 A Phase 3, randomized, placebo-controlled, 12-week double-blind study, followed by a non-controlled extension treatment period, to assess the efficacy and safety of fezolinetant in women suffering from moderate to severe vasomotor symptoms (hot flashes) associated with menopause

 

Migraine:

Amgen, 20190008, A phase 4 comprehensive assessment of Erenumab efficacy in subjects with high frequency episodic migraine with at least 1 previously failed preventative treatment: a global, double-blind, placebo-controlled phase 4 study

Amgen, 20190389, Phase 4, open-label study to evaluate treatment satisfaction with Erenumab in patients with migraine

Teva, TV48125-MH-50039, A long-term, phase 4 study prospective, observational study to evaluate the safety, including cardiovascular safety, of Fremanezumab in patients with migraine in routine clinical practice, non-interventional

Satsuma, STS101-007, A randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of (Dihydroergotamine Nasal Powder) in the acute treatment of migraine

Amgen, 20170703, A Phase 4 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Erenumab in adults with chronic migraine and medication overuse headache

Biohaven, BHV3000-311, Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents >6 to <18 years of age

Impax Labs, IPX229-B16-01, A Phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy and safety of zolmitriptan nasal spray for the treatment of acute migraine in subjects ages 6 to 11 years, with an open-label extension

Evidera, Amgen, A-16821-000-20150133, A prospective observational study to evaluate tolerability and outcomes of prophylactic therapies in migraine

 

Obesity:

Novo Nordisk, NN9924-4558, (Realyse) A long-term comparative effectiveness of once daily semaglutide versus any other oral glucose lower medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk, NN9535-4416, A Phase 4 long-term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

 

Opioid Misuse:

Orexo, OXD01-001, A Phase 3, randomized open-label, parallel-group study to evaluate the efficacy of the digital therapeutic OXD01 (MODIA™) in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder

 

RSV (Respiratory Syncytial Virus):

Janssen, 53718678RSV2004A, A Pilot Phase 2, A randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 at two dose levels in non-hospitalized adult subjects infected with respiratory syncytial virus. 

 

Sickle cell:

Evidera Amgen, RBSC0161, Sickle Cell Disease (SCD) Patient-Reported Outcomes (PRO) Assessment

 

Testosterone Replacement:

AbbVie, M16-100, Phase 4, study on testosterone replacement therapy for assessment of long-term vascular events and efficacy in response in hypogonadal men


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Dr. Steven R. Bauer is the founder and a managing partner of Ballantyne Medical Associates in Charlotte, North Carolina, where he has been practicing since March 2007. His dedication to helping his patients achieve their optimal health is evident in his focus on treating the whole person and keeping in mind the multiple aspects of each of their individual lives.

He graduated cum laude from the department of agriculture and life science in the pre-med program at North Carolina State University. Dr. Bauer then entered the medical school campus of the New York Institute of Technology. After graduating medical school with honors he completed his internship and residency programs at Good Samaritan Hospital Medical Center in New York. Dr. Bauer was then elected to serve as chief resident to complete his final year of training at Good Samaritan. After residency, he went on to become national board-certified in family medicine and osteopathic medicine. Prior to moving to NC in December 2006, he spent nine years in private practice in NY while also working as a Suffolk County New York Department of Health HIV disease specialist in a hospital-operated county clinic. Currently, he is completing a fellowship in anti-aging and regenerative medicine with the Metabolic Medicine Institute - American Academy of Anti-Aging Medicine(A4M).

Dr. Bauer has a passion for medical research and helping bring new pharmaceutical products to market. These new, cutting-edge pharmaceuticals are used by our nation's physicians to help their patients live longer and healthier lives.

He is certified by the Collaborative Institutional Training Initiative ( CITI ) to conduct Human Clinical Research.  As a Principal Investigator for numerous pharmaceutical companies, he conducts research on many new investigational medications. Dr. Bauer has been instrumental in bringing many new drugs to market and FDA product label changes for new indications of current medications. 

Dr. Bauer is also certified through (ACT) Aesthetic Consulting & Training to administer Botox Cosmetic injections to help both his male and female patients maintain a more youthful appearance. He states "It's more than just a physical change my patients' experience, they also have a renewed confidence and possess a more positive and healthy outlook."

Dr. Bauer is also certified by Massachusetts based Cynosure in the use of SculpSure, ICON, PicoSure, Pelleve and Pellefirm laser and light-based cosmetic procedures.

He is a founding and current board member of Independent Physicians of the Carolina’s (IPC), a member of the North Carolina Medical Society (NCMS), American College of Osteopathic Family Physicians (ACOFP), American Academy of Anti Aging Medicine (A4M), American Academy of HIV Medicine (AAHIVM), Concierge Choice Physicians (CCP) and he is the lead physician to the 10-13 (officer down) Club of Charlotte which encompasses hundreds of retired and active police officers.

 

Clinical Trials conducted by Dr. Bauer as P.I. ( Principle Investigator )

 

ADHD (Attention-Deficit/Hyperactivity Disorder):

Otsuka, 405-201-00017, A Phase 3, multicenter, open-label, long-term trial evaluating the long-term safety and tolerability of once-daily centanafadine capsules in children and adolescents with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00015, A Phase 3, open-label, 52-week, multicenter trial evaluating the long-term safety and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder

Otsuka, 405-201-00014, A Phase 3, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial evaluating the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (trial 405-201-00014)

 

Asthma:

AstraZeneca, D5982C00007, A Phase 3, randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 weeks variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate MDI and Symbicort® Pressurized MDI in Adult and adolescent participants  with inadequately controlled asthma (KALOS)

Cipla, U-FS-MU-AS3120, A phase 4 multicenter, randomized, parallel-group, placebo-controlled, 4-week clinical endpoint bioequivalence study comparing fluticasone propionate/salmeterol 100/50 mcg inhalation powder (Cipla Ltd. India) with Advair® Diskus 100/50 mcg (GlaxoSmithKline, USA) in asthma patients

Bond Avillion 2, AV003, A Phase 3 Long-term, randomized, double-blind, multicenter, parallel group, evaluating the efficacy and safety of PT027 compared to PT007 administered as needed in response to symptoms in symptomatic adults and children 4 years of age or older with asthma

 

Cancer:

Clinlogic Research, CGx-02252019 , A study to evaluate the clinical benefit of using hereditary cancer genome diagnostics to assess overall hereditary genetic cancer risk profile to help guide physicians to pursue preventative measures which may lead to early detection and treatment of the cancer condition

 

Chlamydia:

Evofem Biosciences, EVO100-311, A Phase 3 double-blind placebo-controlled efficacy trial EVO100 vaginal gel for the prevention of urogenital chlamydia trachomatis and neisseria gonorrhea (EVOGUARD)

 

COPD (Chronic Obstructive Pulmonary Disease):

Sanofi Aventis EFC15805, A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 52- week pivotal study to assess the efficacy, safety, and tolerability of dupilumab in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation

Boehringer Ingelheim 1237-0064 The AIRWISE study, assessment in a real world setting of the effect of inhaled steroid-based triple therapy versus the combination of tiotropium and olodaterol on reducing COPD exacerbations

AstraZeneca, D3251C00004 A Phase 3, randomized, double-blind, double dummy, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase iii study to evaluate the efficacy and safety of 3 doses of benralizumab (medi-563) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) with a history of COPD exacerbations (terranova)

 

COVID-19:

AstraZeneca, D8851C00001 A Phase 3, randomized, double-blind, placebo controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

AstraZeneca, D8851C00001, unblinded A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to determine the safety and efficacy of AZD7442 for the treatment of COVID-19 in non-hospitalized adults

Sorrento Therapeutics, AMG-COV-201, A Phase 2, randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, and efficacy of a single dose of STI-202 (COVI-AMG) in outpatient adults with COVID-19

Revive, RT-003, A Phase 3 multi-center, randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 (ARISE)

Cytomegalovirus:

Moderna, CMV mRNA-1647-P301, A Phase 3, randomized, observer-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1647 Cytomegalovirus (CMV) vaccine in healthy females 16 to 40 years of age

 

Diabetes:

Novo Nordisk, NN9924-4668, A study of patients with onset of type 2 diabetes (T2D) at a young age is a high-risk population with need for intensified therapy

Novo Nordisk, NN1436-4383, A Phase 2, investigational trial comparing the efficacy and safety of once weekly nnc0148-0287 c (insulin 287) versus once daily insulin glargine, both in combination with metformin, with or without dpp-4 inhibitors, in insulin native subjects with type 2 diabetes mellitus

Novo Nordisk, NN9924-4558, (Realyse) A long term comparative effectiveness of once daily semaglutide versus any other oral glucose lowering medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk NN9535-4416, A Phase 4 long term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

Novo Nordisk, NN1250-4252, A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without an oral antidiabetic drug

Novo Nordisk, NN2211-4315 , A study of LIRA-ADD2SGLT2i - liraglutide versus placebo as add-on to SGLT2 inhibitors

Novo Nordisk, NN2211-4232, A study of the efficacy in controlling glycemia with Victoza® (liraglutide) as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes inadequately controlled with metformin monotherapy and treated in a primary care setting

Novo Nordisk, NN9924-4233, A study of the efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise 

Novo Nordisk, NN9924-4222, A study of the efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes

Novo Nordisk, NN1250-3998, A randomized, double blind cross over trial comparing the safety and efficacy of insulin degludec and insulin glargine, with or without OADs in subjects with type 2 diabetes

Novo Nordisk, NN9535-3623, A study of the efficacy and safety of semaglutide once weekly versus placebo in drug-naive subjects with type 2 diabetes

 

Gout:

LG Chem, LG-GDCL002, A Phase 2, randomized, multicenter, double-blind, parallel-group, placebo-controlled, dose finding study to assess the efficacy and safety of LC350189 in gout patients with hyperuricemia

 

Hot Flashes:

Astellas, 2693-CL-0304, A Phase 3, randomized, placebo-controlled, double-blind clinical study to investigate the long-term safety of Fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301, A Phase 3, randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

 

Hypogonadism:

AbbVie, M19-161, A Phase 4, 24-hour ambulatory randomized blood pressure monitoring study in hypogondal men receiving testosterone replacement therapy

 

IBS (Irritable Bowel Syndrome):

OrphaMed, Inc., OM-201,, A Phase 2, double-blind, placebo-controlled, responsive adaptive randomization study of ORP-101 in patients with irritable bowel syndrome with diarrhea (IBS-D)

Synergy Pharmaceuticals, SP304203-06,, an open-label, long-term safety and tolerability study of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304203-04,, a randomized, 12-week, double-blind, placebo-controlled study of the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

Synergy Pharmaceuticals, SP304-20212, a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study to assess the safety and efficacy of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C)

 

Influenza:

Roche Genentech, CV43551, A Phase 3, multicenter, single-arm, open-label study of direct transmission of influenza from otherwise healthy pediatric index patients treated with Baloxavir Marboxil to household contacts

Hoffman - La Roche MV40618, A Phase 3B, multicenter, randomized, double-blind, placebo controlled, clinical efficacy study of Baloxavir Marboxil for the reduction of direct transmission of influenza from otherwise healthy patients to household contacts

Emergo Therapeutics NKT-202, A Phase 2B, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy and safety of Norketotifen in the treatment of acute uncompromised influenza-like illness

Genentech was F. Hoffman-La Roche Ltd., CP40563 A multicenter, randomized, double-blind, active (Oseltamivir)-controlled study to assess the safety, pharmacokinetics, and efficacy of Baloxavir Marboxil in otherwise healthy pediatric patients 1 to <12 years of age with influenza-like symptoms

Janseen, 63623872FLZ3002, A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of pimodivir in combination with the standard of care treatment in adolescent, adult, and elderly non-hospitalized subjects with influenza A infection who are at risk of developing complications

Shionogi, 1601T0831, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in otherwise healthy patients with influenza

Shionogi, 1602T0832, A Phase 3, multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in patients with influenza at high risk for influenza complications

 

Menopause:

Astellas, 2693-CL-0304 A Randomized, placebo-controlled, double-blind phase 3 clinical study to investigate the long-term safety of fezolinetant in women suffering from vasomotor symptoms (hot flashes) associated with menopause

Astellas, 2693-CL-0301 A Phase 3, randomized, placebo-controlled, 12-week double-blind study, followed by a non-controlled extension treatment period, to assess the efficacy and safety of fezolinetant in women suffering from moderate to severe vasomotor symptoms (hot flashes) associated with menopause

 

Migraine:

Amgen, 20190008, A phase 4 comprehensive assessment of Erenumab efficacy in subjects with high frequency episodic migraine with at least 1 previously failed preventative treatment: a global, double-blind, placebo-controlled phase 4 study

Amgen, 20190389, Phase 4, open-label study to evaluate treatment satisfaction with Erenumab in patients with migraine

Teva, TV48125-MH-50039, A long-term, phase 4 study prospective, observational study to evaluate the safety, including cardiovascular safety, of Fremanezumab in patients with migraine in routine clinical practice, non-interventional

Satsuma, STS101-007, A randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of (Dihydroergotamine Nasal Powder) in the acute treatment of migraine

Amgen, 20170703, A Phase 4 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Erenumab in adults with chronic migraine and medication overuse headache

Biohaven, BHV3000-311, Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents >6 to <18 years of age

Impax Labs, IPX229-B16-01, A Phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy and safety of zolmitriptan nasal spray for the treatment of acute migraine in subjects ages 6 to 11 years, with an open-label extension

Evidera, Amgen, A-16821-000-20150133, A prospective observational study to evaluate tolerability and outcomes of prophylactic therapies in migraine

 

Obesity:

Novo Nordisk, NN9924-4558, (Realyse) A long-term comparative effectiveness of once daily semaglutide versus any other oral glucose lower medication in a real-world adult population with type 2 diabetes on metformin monotherapy in US-based health care systems a pragmatic trial

Novo Nordisk, NN9535-4416, A Phase 4 long-term study of comparative effectiveness of once weekly semaglutide versus standard of care in a real-world US adult population with type 2 diabetes a randomized pragmatic clinical trial

 

Opioid Misuse:

Orexo, OXD01-001, A Phase 3, randomized open-label, parallel-group study to evaluate the efficacy of the digital therapeutic OXD01 (MODIA™) in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder

 

RSV (Respiratory Syncytial Virus):

Janssen, 53718678RSV2004A, A Pilot Phase 2, A randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 at two dose levels in non-hospitalized adult subjects infected with respiratory syncytial virus. 

 

Sickle cell:

Evidera Amgen, RBSC0161, Sickle Cell Disease (SCD) Patient-Reported Outcomes (PRO) Assessment

 

Testosterone Replacement:

AbbVie, M16-100, Phase 4, study on testosterone replacement therapy for assessment of long-term vascular events and efficacy in response in hypogonadal men


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