Aaron Hartman MD

MD, MAR, ABAARM, FAAMFM, FAAFP, DABFM, DABIM,DAIHM, IFMCP

Research Accomplishments

Publications

Jason Haffi zulla, Aaron Hartman, Melanie Hoppers, Harvey Resnick, Steve Samudrala, Christine Ginocchio, Matthew Bardin, Jean-François Rossignol, for the US Nitazoxanide Infl uenza Clinical Study Group* Effect of nitazoxanide in adults and adolescents with acute uncomplicated infl uenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis 2014; 14: 609–18

Clinical Research Activities

Note: Some of Dr. Hartman’s research has been omitted to comply with regulations pertaining to controlled substances (automated scans cannot always discern between research and advertising). If you are a media representative looking for a full medical biography, please request a full medical biography via our contact form.

2021

“A Double-Blinded, Placebo-controlled, Double Dummy, Multicenter Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose lowering Agents.”

“A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS”

2020

“A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)”

“24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy”

2019

“A 24 –week multi-center, double-blind, placebo controlled dose-range finding study to investigate the efficacy and safety of oral QBW251 in COPD patients on triple inhaled therapy (LABA/LAMA/ICS)”

“A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF 2 DOSES COMPARED TO 3 DOSES OF CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER”

“A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)”

“A Randomized, Blinded, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol in Treatment of Subjects with Asthma”

“An 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”

“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”

2018

”SELECT - Semaglutide effects on cardiovascular outcomes in people with  overweight or obesity”

“A randomized, multiple-dose, parallel group design consisting of a singleblinded 2-week placebo Run-in Period followed by an investigator-blinded 4-week Treatment Period with placebo, test product (generic fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder), or reference product (Advair 100/50)”

“A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma”

“A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)”

“Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study”

“A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis”

2017

“A Phase 3, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And Older”

 “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 oral anti-diabetic drugs.”

“A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN”

2016

”A 38 week trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.”

“DUAL™ Vlll - Durability; A 104 week clinical trial comparing long term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine ttierapy in subjects witti type 2 diabetes mellitus”

2015

“DUAL™ VII — A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) vs basal-bolus therapy in subjects with type 2 diabetes mellitus”

“A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD”

“A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to assess cardiovascular outcomes following treatment with ertugliflozin (MK-8835/PF-04971729) in subjects with Type 2 Diabetes Mellitus and Established vascular disease”

“Phase 3 Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects”

“14-181-08 A Phase 3 Multicenter, Open-Label, 52-Week Study to Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain.”

2014

“A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout”

“A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid and Long-Acting ?2-Agonist (D2210C00008)

“A Long-Term Extension Study of Lesinurad in Combination with Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol”

2013

“A Long-Term Extension Study of Lesinurad in Combination with Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol”

“A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder”

“A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events”

“Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination with Insulin Glargine and Metformin in Adults with Type 2 Diabetes”

“Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients with Moderate to Very Severe COPD (ASCENT COPD)”

“A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout”

“A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/ Benzoyl Peroxide 5%Topical Gel (Taro Pharmaceuticals, Inc.) to Benzaclin ® Topical Gel Clindamycin1%/ Benzoyl Peroxide 5% (Sanofi Aventis) in the Treatment of Acne Vulgaris”

“A multi-center, randomized, double-blind, double-dummy, parallel-group dose-finding study to evaluate the change in HbA1c after 12 weeks monotherapy with seven doses of LIK066 compared with placebo or sitagliptin in patients with type 2 diabetes”

“A 28-Week, Multi-Center, Randomized, Double-Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control”

“A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo”

“A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (diclofenac sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis”

“A Phase III Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide and Nitazoxanide plus Oseltamivir in the Treatment of Acute Uncomplicated Influenza”

2012

“A multi-center, randomized, double-blind, 52-week study to assess the safety of QVA149 compared to QAB149 in patients with Chronic Obstructive Pulmonary Disease (COPD) who have moderate to severe airflow limitation”

“A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects with Gout who have had an Inadequate Hypouricemic Response to Standard of Care Allopurinol”

“The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.”

“A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease”

“An 8-week randomized, open label, multi-center study to study to evaluate the efficacy and safety of oral aliskiren 300 mg once daily under light meal versus fasted condition in patients with hypertension”

“A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome”

“Prospective Observational Study to Evaluate Persistence With Prolia®(Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice”

“SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/ Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma”

2012 “A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma”

2011

“A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects with Type 2 Diabetes Mellitus”

“A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) with Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in Patients with Osteoarthritis of the Knee”

“A 36-week open-label extension study of CACZ885H2361 on the safety and tolerability of canakinumab 150 mg s.c. pre-filled syringe (PFS) in treating acute gouty arthritis flares in frequently flaring patients”

“A randomized, double-blind, active-controlled study of canakinumab (ACZ885) pre-filled syringes or reconstituted lyophilizate versus triamcinolone acetonide for treating acute gouty arthritis flares in frequently flaring patients”

2010

“A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza”

“TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control”

“A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects with Severe Hypertriglyceridemia”

“The PROMISE Trial — Prospective Multicenter Imaging Study for Evaluation of Chest Pain”

2010 “A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes”