MedPath

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Behavioral: Diet
Behavioral: Exercise
Registration Number
NCT01472185
Lead Sponsor
Gilead Sciences
Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones \[TZDs\] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
465
Inclusion Criteria
  • Written informed consent
  • Males and females, 18 to 75 years old, inclusive
  • Documented history of T2DM
  • Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days (TZDs for at least 24 weeks) prior to screening
  • Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at screening
  • HbA1c 7% - 10%, inclusive at screening and at the end of the Qualifying Period (Day 14 +2 days)
  • Fasting serum glucose (FSG) of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at screening and at the end of the Qualifying Period (Day 14 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 125 mg/dL (6.9 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.
  • Fasting serum C-peptide ≥ 0.8 ng/mL at screening
  • Able and willing to comply with all study procedures during the course of the study
  • Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception methods from screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
  • At least 80% compliant with dosing during the Qualifying Period
Exclusion Criteria
  • History of or current diagnosis of type 1 diabetes mellitus
  • History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
  • History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to screening or ≥ 2 episodes within 6 months prior to screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior
  • Clinically significant complications of diabetes that, in the judgment of the investigator, would make the subject unsuitable to participate in this study
  • History of any clinically significant cardiovascular or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent coronary revascularization [including coronary artery bypass graft procedures or percutaneous coronary intervention], transient ischemic attack or ischemic stroke) ≤ 3 months prior to screening
  • Inadequately controlled or unstable hypertension as defined by systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at screening and randomization
  • Prolonged QTc interval > 500 msec by ECG at screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
  • History of bariatric surgery at any time in the past or any other surgery < 2 months before screening, or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the Medical Monitor.
  • Any other hospitalization in the 14 days prior to screening or planned hospitalization at any time during the study
  • Significant weight change (± 5%) < 2 months prior to screening or on a weight-loss program and is not in the maintenance phase at screening
  • Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at screening or undergoing any type of dialysis at screening or planning to undergo any type of dialysis during the course of the study.
  • History of liver cirrhosis (Child-Pugh Class A, B or C)
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x ULN and/or serum total bilirubin > 2.0 mg/dL
  • History of cancer (except non-melanomic skin cancers or cervical in situ) within 5 years prior to screening
  • History of alcohol or other drug abuse < 12 months prior to screening
  • Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that, in the opinion of the investigator, could interfere with conduct of the study or interpretation of the data
  • Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or any of its excipients
  • Treatment with strong or moderate cytochrome (CYP)3A inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
  • Treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, sirolimus) within 14 days prior to randomization
  • Treatment with simvastatin at a daily dose > 20 mg or lovastatin at a daily dose > 40 mg, within 14 days prior to randomization
  • Weight-loss medication or anti-obesity medication (prescription or nonprescription) < 3 months prior to screening
  • Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 90 days prior to screening and for the duration of the study
  • Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study
  • If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization
  • Hemoglobin < 12 g/dL for males; or < 11 g/dL for females, at screening
  • Participation in another clinical study involving an investigational drug or device < 30 days prior to screening; participation in another clinical study involving an antihyperglycemic therapy < 90 days prior to screening
  • Donation of blood < 2 months prior to screening; plans to donate blood while participating in the study
  • Females who are pregnant or breastfeeding
  • Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or would compromise the quality of the clinical study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
PlaceboExerciseQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
PlaceboDietQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
RanolazineExerciseQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
RanolazineRanolazineQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
RanolazinePlaceboQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
RanolazineDietQualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24Baseline; Week 24

The average (mean) change from baseline in HbA1c at Week 24 was analyzed.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With HbA1c < 7% at Week 24Week 24
Change From Baseline in Fasting Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.

Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.

Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time \[T\] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received.

Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.

Trial Locations

Locations (157)

Thunderbird Internal Medicine/Clinical Research Advantage

🇺🇸

Glendale, Arizona, United States

North Central Arkansas Medical Associates

🇺🇸

Mountain Home, Arkansas, United States

Desert Sun Clinical Research, LLC

🇺🇸

Tucson, Arizona, United States

NZOZ PrimaMED

🇵🇱

Kielce, Swietokrzyskie, Poland

NZOZ Specjalistyczna Przychodnia Medyczna Atopia

🇵🇱

Krakow, Poland

Vitadiab SRL - Cabinet Medical Dr. Barabas Alina SRL

🇷🇴

Brasov, Jud Brasov, Romania

Consultmed SRL

🇷🇴

Iasi, Jud. Iasi, Romania

CMI Diabet Nutritie Boli Metabolice Dr. Pop Lavinia

🇷🇴

Baia Mare, Jud. Maramures, Romania

CMI Morosanu V. Magdalena

🇷🇴

Galati, Judetul Galati, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati

🇷🇴

Galati, Judetul Galati, Romania

Diabmed Dr. Popescu Alexandrina SRL

🇷🇴

Ploiesti, Judetul Prahova, Romania

Tehnomed Trading Srl

🇷🇴

Bucharest, Romania

GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF

🇷🇺

Chita, Russian Federation

"Clinic of New Medical Technology" Company Limited

🇷🇺

Dzerzhinskiy, Russian Federation

The Urals State Medical Academy

🇷🇺

Ekaterinburg, Russian Federation

"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky

🇷🇺

Krasnoyarsk, Russian Federation

State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District"

🇷🇺

Moscow, Russian Federation

Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov

🇷🇺

St. Petersburg, Russian Federation

Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery

🇷🇺

Yaroslavl, Russian Federation

Infosphere Clinical Research

🇺🇸

West Hills, California, United States

PAB Clinical Research

🇺🇸

Brandon, Florida, United States

Suncoast Clinical Research

🇺🇸

New Port Richey, Florida, United States

Regenerate Clinical Trials

🇺🇸

South Miami, Florida, United States

CTL Research

🇺🇸

Eagle, Idaho, United States

MD Medical Research

🇺🇸

Oxon Hill, Maryland, United States

LaPorte County Institute for Clinical Research

🇺🇸

Michigan City, Indiana, United States

Clinical Trials Management, LLC

🇺🇸

Metairie, Louisiana, United States

Clinical Research Solution

🇺🇸

New York, New York, United States

Associated Internal Medicine Specialists, P.C.

🇺🇸

Battle Creek, Michigan, United States

Albuquerque Clinical Trials

🇺🇸

Albuquerque, New Mexico, United States

University of New Mexico Clinical and Translational Science Center

🇺🇸

Albuquerque, New Mexico, United States

PharmQuest

🇺🇸

Greensboro, North Carolina, United States

PMG Research of Charlotte

🇺🇸

Charlotte, North Carolina, United States

Clinical Inquest Center, Ltd.

🇺🇸

Beavercreek, Ohio, United States

PMG Research of Salisbury

🇺🇸

Salisbury, North Carolina, United States

Blair Medical Associates, Inc, Station Medical Center

🇺🇸

Altoona, Pennsylvania, United States

Southeastern Research Associates, Inc.

🇺🇸

Taylors, South Carolina, United States

HCCA Clinical Research Solution

🇺🇸

Jackson, Tennessee, United States

HCCA Clinical Research Solutions

🇺🇸

Smyrrna, Tennessee, United States

New Phase Research & Development

🇺🇸

Knoxville, Tennessee, United States

Metabolic Center of Dr. Katarina Raslova Ltd.

🇸🇰

Bratislava, Bratislavsky kraj, Slovakia

ENDIAMED s.r.o

🇸🇰

Dolny Kubin, Zilinsky kraj, Slovakia

Worthwhile Clinical Trials

🇿🇦

Benoni, South Africa

V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine

🇺🇦

Kyiv, Ukraine

Vinnytsya Regional Clinical Endocrinology Dispensary

🇺🇦

Vinnytsya, Ukraine

Zhytomyr Regional Clinical Hospital

🇺🇦

Zhytomyr, Ukraine

Eclipse Clinical Research

🇺🇸

Tucson, Arizona, United States

Southland Clinical Research Center, Inc.

🇺🇸

Fountain Valley, California, United States

Paul W. Davis, MD, Private Practice

🇺🇸

Pine Bluff, Arkansas, United States

Global Research Management

🇺🇸

Glendale, California, United States

Spectrum Clinical Research Institute, Inc

🇺🇸

Moreno Valley, California, United States

Clearview Medical Research LLC

🇺🇸

Santa Clarita, California, United States

A G A Clinical Trials

🇺🇸

Hialeah, Florida, United States

Kanizsai Dorottya Hospital

🇭🇺

Nagykanizsa, Hungary

NZOZ Centrum Badan Klinicznych

🇵🇱

Wroclaw, Dolnoslaskie, Poland

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii

🇵🇱

Lodz, Lodzkie, Poland

NZOZ Polimedica

🇵🇱

Zgierz, Lodzkie, Poland

LANDA - Specjalistyczne Gabinety Lekarskie

🇵🇱

Krakow, Malopolskie, Poland

NZOZ Centrum Badan Klinicznych Oswiecim

🇵🇱

Oswięcim, Malopolskie, Poland

Manassas Clinical Research Center

🇺🇸

Manassas, Virginia, United States

IRC Clinics, Inc

🇺🇸

Towson, Maryland, United States

Nemocnice s poliklinikou Havirov

🇨🇿

Havirov, Moravskoslezsky kraj, Czech Republic

Humble Cardiology Associates

🇺🇸

Humble, Texas, United States

Burke Internal Medicine & Research

🇺🇸

Burke, Virginia, United States

Juno Research, LLC

🇺🇸

Katy, Texas, United States

Drug Research Center

🇭🇺

Balatonfüred, Hungary

Borbanya Praxis Kft., Outpatient Clinic

🇭🇺

Nyíregyháza, Hungary

NZOZ Cereo-Med Sp. z o.o.

🇵🇱

Lodz, Poland

Miedzyleski Szpital Specjalistyczny w Warszawie

🇵🇱

Warszawa, Poland

Spital Clinic Judetean de Urgenta Oradea Stationarul 1

🇷🇴

Oradea, Jud Bihor, Romania

Medifarma 98

🇭🇺

Nyíregyháza, Hungary

NZOZ Centrum Medyczne Szpital Sw. Rodziny

🇵🇱

Lodz, Lodzkie, Poland

Synexus Hungary Ltd

🇭🇺

Budapest, Hungary

Markhot Ferenc Hospital

🇭🇺

Eger, Hungary

Zala County Hospital

🇭🇺

Zalaegerszeg, Hungary

NZOZ Regionalna Poradnia Diabetologiczna

🇵🇱

Wroclaw, Dolnoslaskie, Poland

NZOZ Centrum Osteporozy i Chorob Kostno-Stawowych J.Badurski Sp.j.

🇵🇱

Bialystok, Poland

Leszek Romanowski Barbara Romanowska "DIABET" Centrum Medyczne s.c.

🇵🇱

Chrzanów, Poland

Specjalistyzny Ośrodek Lecznicz-Badawczy

🇵🇱

Ostroda, Poland

3rd Central Military Clinical Hospital named after A.A.Vishnevskogo

🇷🇺

Arkhangelskoe, Russian Federation

Kemerovo Regional Clinical Hospital

🇷🇺

Kemerovo, Russian Federation

City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod

🇷🇺

Nizhniy Novgorod, Russian Federation

Central Clinical Hospital of Russian Academy of Sciences

🇷🇺

Moscow, Russian Federation

Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu"

🇷🇴

Bucuresti, Romania

O.D. Medica Srl

🇷🇴

Bucuresti, Romania

Centru Medical Dr. Negrisanu

🇷🇴

Timisoara, jud. Timis, Romania

Novosibirsk State Medical University

🇷🇺

Novosibirsk, Russian Federation

Scientific Research Institute of Physiology of Siberian Department RAMS

🇷🇺

Novosibirsk, Russian Federation

City Hospital # 38 named after N A Semashko

🇷🇺

Pushkin, Russian Federation

Saint-Petersburg City Outpatient Clinic#37

🇷🇺

St. Petersburg, Russian Federation

ANO "Medical Centre "XXI century"

🇷🇺

St. Petersburg, Russian Federation

Krestovsky Island Medical Institute, LLC

🇷🇺

St. Petersburg, Russian Federation

LLC "Reafan"

🇷🇺

Novosibirsk, Russian Federation

Rostov State Medical University

🇷🇺

Rostov-on-Don, Russian Federation

Ryazan State Medical University

🇷🇺

Ryazan, Russian Federation

Medinet, LLC

🇷🇺

St. Petersburg, Russian Federation

North-Western State Medical Unversity n.a. I.I.Mechnikov

🇷🇺

St. Petersburg, Russian Federation

Military Medical Academy named after S.M. Kirov

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109"

🇷🇺

St. Petersburg, Russian Federation

Clinical Hospital #122 n.a. Sokolov of FMBA

🇷🇺

St. Petersburg, Russian Federation

Center "Diabetes", LLC

🇷🇺

Samara, Russian Federation

Smolensk State Medical Academy, Sanatorium-Preventorium

🇷🇺

Smolensk, Russian Federation

Alexanders City Hospital

🇷🇺

St. Petersburg, Russian Federation

St. Elizabeth City Hospital

🇷🇺

St. Petersburg, Russian Federation

International Medical Center "SOGAZ", LLC

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg City Pokrovskaya Hospital

🇷🇺

St. Petersburg, Russian Federation

Tyumen State Medical Academy

🇷🇺

Tyumen, Russian Federation

Voronezh Regional Clinical Hospital #1

🇷🇺

Voronezh, Russian Federation

City Hospital named after N.A.Semashko

🇷🇺

Yaroslavl, Russian Federation

Clinical Hospital for Emergency Care named after N.V. Solovyov

🇷🇺

Yaroslavl, Russian Federation

Yaroslavl Regional Clinical Hospital

🇷🇺

Yaroslavl, Russian Federation

Clinical Center of Kragujevac

🇷🇸

Kragujevac, Serbia

METABOLKLINIK s.r.o.

🇸🇰

Bratislava, Bratislavsky kraj, Slovakia

Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

MEDIVASA s.r.o.

🇸🇰

Zilina, Zilinsky kraj, Slovakia

Centre for Diabetes, Asthma and Allergy

🇿🇦

Johannesburg, South Africa

Newkwa Medical Centre

🇿🇦

Newlands West, Durban, South Africa

Netcare Umhlanga Medical Centre

🇿🇦

Kwa Zulu Natal, Umhlanga, Durban, South Africa

Aliwal Shoal Medical & Clinical Trial Centre

🇿🇦

Kwa Zulu Natal, South Africa

"Diabetologicka a metabolicka ambulancia Human-care s.r.o"

🇸🇰

Kosice, Kosicky kraj, Slovakia

ARETEUS s.r.o., Diabetologicka ambulancia

🇸🇰

Trebisov, Kosicky kraj, Slovakia

MediVet s.r.o.

🇸🇰

Malacky, Slovakia

Global Clinical Trials

🇿🇦

Pretoria, South Africa

Soweto Clinical Trial Centre

🇿🇦

Johannesburg, South Africa

City Clinical Hospital#9, Dnipropetrovsk State Medical Academy

🇺🇦

Dnipropetrovsk, Ukraine

Educational Scientific Medical Centre "University clinic" of Donetsk National Medical University n.a. M.Gorkiy

🇺🇦

Donetsk, Ukraine

State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukraine"

🇺🇦

Kharkiv, Ukraine

Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company

🇺🇦

Kyiv, Ukraine

National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District

🇺🇦

Kyiv, Ukraine

Municipal Institution Lutsk City Clinical Hospital

🇺🇦

Lutsk, Ukraine

Lviv Regional Endocrinology Dispensary

🇺🇦

Lviv, Ukraine

Odessa State Medical University

🇺🇦

Odesa, Ukraine

Public Institution "City Outpatients' Hospital #20"

🇺🇦

Odesa, Ukraine

Helderberg Clinical Trials Centre

🇿🇦

Somerset West, South Africa

Tiervlei Trial Centre

🇿🇦

Western Cape, South Africa

Moscow City Clinical Hospital #63

🇷🇺

Moscow, Russian Federation

National Research Institute

🇺🇸

Los Angeles, California, United States

Sacramento Heart and Vascular Medical Associates

🇺🇸

Sacramento, California, United States

Boca Raton Clinical Research Associates, Inc

🇺🇸

Boca Raton, Florida, United States

Florida Research Network, LLC

🇺🇸

Gainesville, Florida, United States

Synergy Therapeutic Partners

🇺🇸

Atlanta, Georgia, United States

Central Phoenix Medical Clinic

🇺🇸

Phoenix, Arizona, United States

Precision Research Organization

🇺🇸

Miami Lakes, Florida, United States

Baptist Diabetes Associates

🇺🇸

Miami, Florida, United States

Florida Institute for Clinical Research LLC

🇺🇸

Orlando, Florida, United States

Cedar-Crosse Research Center

🇺🇸

Chicago, Illinois, United States

Excel Clinical Research, LLC

🇺🇸

Houston, Texas, United States

Infinity Research Group, LLC

🇺🇸

Oklahoma City, Oklahoma, United States

The University of Texas Southwestern Medical Center at Dallas

🇺🇸

Dallas, Texas, United States

Texas Center for Drug Development, PA

🇺🇸

Houston, Texas, United States

Cetero Research

🇺🇸

San Antonio, Texas, United States

Jean Brown Research

🇺🇸

Salt Lake City, Utah, United States

Discovery Clinical Trials

🇺🇸

San Antonio, Texas, United States

Highland Clinical Research

🇺🇸

Salt Lake City, Utah, United States

Jacksonville Center for Clinical Research

🇺🇸

Jacksonville, Florida, United States

NextPhase Clinical Trials, Inc.

🇺🇸

Miami Beach, Florida, United States

Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow

🇷🇺

Moscow, Russian Federation

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