Clinical trial NCT01137474: A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-06-04
Enrollment: 2996
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.


Eligibility criteria: Key inclusion criteria

* Participants willing and able to give signed and written informed consent
* Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
* Mean 24-hour BP\>=130/80 mmHg determined by ABPM
* Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
* C-peptide level ≥0.8 ng/mL
* Body mass index ≤ 45.0 kg/m\^2

Key exclusion criteria

* Aspartate aminotransferase or alanine aminotransferase level \>3\*upper limit of normal (ULN)
* Serum total bilirubin level \>1.5\*ULN
* Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
* Estimated creatinine clearance of \<60 mL/min
* Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
* Creatine kinase \>3\*ULN
* Positive for hepatitis B surface antigen
* Positive for antihepatitis C virus antibody
* Abnormal free T4 value
* History of diabetes insipidus
* Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* History of malignant and accelerated hypertension
* Known or suspected secondary hypertension
* Any of the following within 6 months of enrollment visit:

  * Myocardial infarction
  * Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
  * Unstable angina
  * Unstable congestive heart disease or New York Heart Association Class III or IV
  * Transient ischemic attack or significant cerebrovascular disease
  * Unstable or previously undiagnosed arrhythmia

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Ozark
country: United States
facility: Iicr, Inc. (International Institute Of Clinical Research)
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: 43rd Medical Associates
state: Arizona
city: Tempe
country: United States
facility: Central Phoenix Medical Clinic, Llc
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage/Desert Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Aureus Research, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Anaheim
country: United States
facility: Cmp Research
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Chino
country: United States
facility: Catalina Research Institute, Llc
state: California
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Huntington Park
country: United States
facility: Del Rosario Medical Clinic, Inc.
state: California
city: Huntington Park
country: United States
facility: Time Clinical Research Inc.
state: California
city: Lomita
country: United States
facility: Marina Raikhel, M.D., F.A.A.F.P
state: California
city: Los Angeles
country: United States
facility: Clinica Medica San Miguel
state: California
city: Los Angeles
country: United States
facility: American Institute Of Research
state: California
city: Los Angeles
country: United States
facility: Randall G. Shue, D.O.
state: California
city: Los Angeles
country: United States
facility: National Research Inst
state: California
city: Los Angeles
country: United States
facility: Quest Diagnostics West Hills
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz,Md.,Inc.
state: California
city: Orange
country: United States
facility: Sds Clinical Trials
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Inc.
state: California
city: Sacramento
country: United States
facility: Quality Control Research, Inc
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials, Inc.
state: California
city: Santa Monica
country: United States
facility: Orrin M. Troum, Md And Medical Associates
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: West Hills
country: United States
facility: Infosphere Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Aurora Family Medicine, P.C.
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, Llc
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, Llc
state: Connecticut
city: Boynton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Chipley
country: United States
facility: Family Care Associates Of Nw Fl
state: Florida
city: Clearwater
country: United States
facility: Innovative Research Of West Florida, Inc
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research Of South Florida
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, Llc
state: Florida
city: Doral
country: United States
facility: In Vivo Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Hialeah
country: United States
facility: The Community Research Of South Florida
state: Florida
city: Miami Beach
country: United States
facility: Newphase Clinical Trials, Inc.
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Flcri Global Research, Llc
state: Florida
city: Miami
country: United States
facility: International Research Associates, Llc
state: Florida
city: Miami
country: United States
facility: Clinical Research Of Miami, Inc.
state: Florida
city: Miami
country: United States
facility: Apf Research, Llc
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc.
state: Florida
city: Miami
country: United States
facility: Medical Research Marseilles
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates, Pa
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research, Llc
state: Florida
city: South Miami
country: United States
facility: South Miami Clinical Research, Llc
state: Florida
city: St Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute For Clinical Research
state: Georgia
city: Bainbridge
country: United States
facility: Bainbridge Medical Associates
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, Llc
state: Georgia
city: Duluth
country: United States
facility: In-Quest Medical Research, Llc
state: Georgia
city: Perry
country: United States
facility: Middle Georgia Clinical Research Center, Llc
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: James R. Herron, Md, Ltd
state: Illinois
city: O?Fallon
country: United States
facility: So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
state: Illinois
city: Springfield
country: United States
facility: Springfield Diabetes And Endocrine Center
state: Illinois
city: Avon
country: United States
facility: American Health Network Of Indiana Llc
state: Indiana
city: Brownsburg
country: United States
facility: Investigators Research Group, Llc
state: Indiana
city: Franklin
country: United States
facility: American Health Network Of In Llc
state: Indiana
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research, Inc.
state: Indiana
city: Muncie
country: United States
facility: American Health Network Of In Llc
state: Indiana
city: Baton Rouge
country: United States
facility: Medical Development Centers, Llc
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Bangor
country: United States
facility: Acadia Clinical Research, Llc
state: Maine
city: Silver Spring
country: United States
facility: Alternative Primary Care
state: Maryland
city: Brookline
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Fall River
country: United States
facility: Genesis Clinical Research, Llc
state: Massachusetts
city: New Bedford
country: United States
facility: Hci-Metromedic Walk-In Medical Office
state: Massachusetts
city: Watertown
country: United States
facility: Atlantic Clinical Trials, Llc
state: Massachusetts
city: Novi
country: United States
facility: Providence Park Clinical Research
state: Michigan
city: Biloxi
country: United States
facility: The Center For Clinical Trials
state: Mississippi
city: Jackson
country: United States
facility: Phillips Medical Services, Pllc
state: Mississippi
city: Rolling Fork
country: United States
facility: Jackson Clinic
state: Mississippi
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Center For Clinical Research
state: Missouri
city: Kansas City
country: United States
facility: Kcumb Dybedal Clinical Research Center
state: Montana
city: Henderson
country: United States
facility: Clin Research Advantage, Inc. James Meli, Do Family Pracice
state: Nevada
city: Las Vegas
country: United States
facility: Office Of Ted Thorp, Md
state: Nevada
city: Las Vegas
country: United States
facility: Independent Clinical Researchers@ Wolfson Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Palm Medical Research Center
state: Nevada
city: Nashua
country: United States
facility: Joslin Diabetes Center Affiliate Of Snhmc
state: New Hampshire
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: North Massapequa
country: United States
facility: Digiovanna Institute For Medical Education & Research
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Charlotte
country: United States
facility: Barat Research Group, Inc.
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Wilmington
country: United States
facility: Pmg Research Of Wilmington Llc
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Canal Fulton
country: United States
facility: Community Health Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Cleveland Sleep Research Center
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Family Care Central
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Yukon
country: United States
facility: Integris Family Care Yukon
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Broomall
country: United States
facility: Southeastern Pa Medical Institute
state: Pennsylvania
city: Feasterville Trevose
country: United States
facility: Abington Memorial Hos/Feasterville Family Health Care Center
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arcuri Clinical Research Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Health Associates - Adult Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Banksville Medical Pc
state: Pennsylvania
city: Reading
country: United States
facility: Research Across America
state: Pennsylvania
city: Uniontown
country: United States
facility: Pish Medical Associates
state: Pennsylvania
city: Warwick
country: United States
facility: Greater Providence Clinical Research, Llc
state: Rhode Island
city: Anderson
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Greenville
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Reseach, Llc
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Research & Medicine, Pllc
state: Tennessee
city: Knoxville
country: United States
facility: Complete Family Care Of Knoxville, Pllc
state: Tennessee
city: Memphis
country: United States
facility: Premier Internal Medicine
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Research Center, Inc.
state: Texas
city: Dallas
country: United States
facility: Krk Medical Research
state: Texas
city: Dallas
country: United States
facility: Research Institute Of Dallas
state: Texas
city: Dallas
country: United States
facility: Internal Medicine Clinical Research
state: Texas
city: Dallas
country: United States
facility: Renaissance Clinical Research And Hypertension Pllc
state: Texas
city: El Paso
country: United States
facility: Sergio F. Rovner, M.D.
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Excel Clinical Research, Llc
state: Texas
city: Houston
country: United States
facility: Lone Star Clinical Research
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research, Inc.
state: Texas
city: Pasadena
country: United States
facility: Med-Olam Clinical Research
state: Texas
city: Plano
country: United States
facility: Lisa E. Medwedeff, Md, Pa
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Abbott Clinical Research Group, Inc.
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinical Research, Pa
state: Texas
city: Sugarland
country: United States
facility: Breco Research, Ltd
state: Texas
city: Sugarland
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Magna
country: United States
facility: Exodus Healthcare Network
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Endocrinology And Diabetes Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Arlington
country: United States
facility: Millennium Clinical Trials Llc
state: Virginia
city: Burke
country: United States
facility: Burke Internal Medicine And Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Suffolk
country: United States
facility: Hampton Roads Center For Clinical Research, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Port Orchard
country: United States
facility: Sound Medical Research
state: Washington
city: Kelowona
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Granby
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Medellin
country: Colombia
facility: Local Institution
state: Antioquia
city: Bogota
country: Colombia
facility: Local Institution
state: Cundinamarca
city: Armenia
country: Colombia
facility: Local Institution
state: Quindio
city: Cali
country: Colombia
facility: Local Institution
state: Valle
city: Barranquilla
country: Colombia
facility: Local Institution
city: Barranquilla
country: Colombia
facility: Local Institution
city: Bogota
country: Colombia
facility: Local Institution
city: Beroun
country: Czech Republic
facility: Local Institution
city: Cheb
country: Czech Republic
facility: Local Institution
city: Havirov
country: Czech Republic
facility: Local Institution
city: Liberec
country: Czech Republic
facility: Local Institution
city: Ostrava
country: Czech Republic
facility: Local Institution
city: Prague 1
country: Czech Republic
facility: Local Institution
city: Praha 4
country: Czech Republic
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Slagelse
country: Denmark
facility: Local Institution
city: Kokkola
country: Finland
facility: Local Institution
city: Oulu
country: Finland
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
state: Bavaria
city: Vellmar
country: Germany
facility: Local Institution
state: Hessen
city: Duisburg
country: Germany
facility: Local Institution
state: Nordrhein-Westfalen
city: Bad Kreuznach
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Karlsruhe
country: Germany
facility: Local Institution
city: Kothen
country: Germany
facility: Local Institution
city: Kronshagen
country: Germany
facility: Local Institution
city: Langenfeld
country: Germany
facility: Local Institution
city: Lueneburg
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Pirna
country: Germany
facility: Local Institution
city: Saarbruecken
country: Germany
facility: Local Institution
city: Gyongyos
country: Hungary
facility: Local Institution
state: Heves
city: Eger
country: Hungary
facility: Local Institution
city: Hatvan
country: Hungary
facility: Local Institution
city: Miskolc
country: Hungary
facility: Local Institution
city: Nagykanizsa
country: Hungary
facility: Local Institution
city: Nyiregyhaza
country: Hungary
facility: Local Institution
city: Satoraljaujhely
country: Hungary
facility: Local Institution
city: Sopron
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Szekszard
country: Hungary
facility: Local Institution
city: Szentes
country: Hungary
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Local Institution
state: Andhra Pradesh
city: New Delhi
country: India
facility: Local Institution
state: Delhi
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Belgaum
country: India
facility: Local Institution
state: Karnatka
city: Indore
country: India
facility: Local Institution
state: Madhya Pradesh
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Delhi
country: India
facility: Local Institution
state: New Delhi
city: Jaipur
country: India
facility: Local Institution
state: Rajasthan
city: Jaipur
country: India
facility: Local Institution
state: Rajasthan
city: Jaipur
country: India
facility: Local Institution
state: Rajasthan
city: Coimbatore
country: India
facility: Local Institution
state: Tamil Nadu
city: Madurai
country: India
facility: Local Institution
state: Tamilnadu
city: Bangalore
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Manipal
country: India
facility: Local Institution
city: Nagpur
country: India
facility: Local Institution
city: Torreon
country: Mexico
facility: Local Institution
state: Coahuila
city: Del. Benito Juarez
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico, Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuautla
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Chihuahua
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
city: Puebla
country: Mexico
facility: Local Institution
city: Queretaro
country: Mexico
facility: Local Institution
city: Veracruz
country: Mexico
facility: Local Institution
city: Chiclayo
country: Peru
facility: Local Institution
state: Lambayeque
city: Lince
country: Peru
facility: Local Institution
state: Lima
city: Arequipa
country: Peru
facility: Local Institution
city: Arequipa
country: Peru
facility: Local Institution
city: Cusco
country: Peru
facility: Local Institution
city: Ica
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Piura
country: Peru
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Chrzanow
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Gdynia
country: Poland
facility: Local Institution
city: Golub-Dobrzyn
country: Poland
facility: Local Institution
city: Kamieniec Zabkowicki
country: Poland
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Ostroda
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroc#Aw
country: Poland
facility: Local Institution
city: WrocB Aw
country: Poland
facility: Local Institution
city: Zamosc
country: Poland
facility: Local Institution
city: Cidra
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Oradea
country: Romania
facility: Local Institution
state: Bihor
city: Oradea
country: Romania
facility: Local Institution
state: Jud. Bihor
city: Timisoara
country: Romania
facility: Local Institution
state: Jud. Timis
city: Targu Mures
country: Romania
facility: Local Institution
state: Mures
city: Targu Mures
country: Romania
facility: Local Institution
state: Mures
city: Ploiesti
country: Romania
facility: Local Institution
state: Prahova
city: Ploiesti
country: Romania
facility: Local Institution
state: Prahova
city: Timisoara
country: Romania
facility: Local Institution
state: Timis
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Satu Mare
country: Romania
facility: Local Institution
city: Sibiu
country: Romania
facility: Local Institution
city: Sibiu
country: Romania
facility: Local Institution
city: Dzerzhinskiy
country: Russian Federation
facility: Local Institution
city: Krasnoyarsk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Yaroslav
country: Russian Federation
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
state: A Coruna
city: Barcelona
country: Spain
facility: Local Institution
city: La Roca Del Valles
country: Spain
facility: Local Institution
city: Peralada
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: