A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01195662
First received: September 3, 2010
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to learn if BMS-512148 (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 (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Placebo matching Dapagliflozin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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 (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline in seated systolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 24-hr ambulatory systolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hr ambulatory diastolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum uric acid [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 810
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, once daily, Up to 12 weeks
Other Name: BMS-512148
Placebo Comparator: Placebo matching Dapagliflozin Drug: Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, Up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
  • Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
  • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
  • C-peptide ≥ 0.8 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2
  • Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

  • Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times the upper limit of normal (ULN)
  • Serum total bilirubin ≥ 1.5 X ULN
  • Creatinine kinase > 3 X ULN
  • Symptoms of severely uncontrolled diabetes
  • History of malignant or accelerated hypertension
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195662

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Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Wilmax Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
43rd Medical Associates
Phoenix, Arizona, United States, 85051
Central Phoenix Medical Center
Tempe, Arizona, United States, 85282
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, United States, 85282
Clinical Research Advantage/Desert Clinical Research
Tempe, Arizona, United States, 85282
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
Aureus Research, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Cmp Research
Anaheim, California, United States, 92805
Catalina Research Institute, Llc
Chino, California, United States, 91710
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
Time Clinical Research Inc.
Huntington Park, California, United States, 90255
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States, 90255
American Institute Of Research
Los Angeles, California, United States, 90017
Randall G. Shue, D.O.
Los Angeles, California, United States, 90023
Clinica Medica San Miguel
Los Angeles, California, United States, 90015
National Research Inst
Los Angeles, California, United States, 90057
Mcs Clinical Trials
Los Angeles, California, United States, 90057
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Valley Clinical Trials
Northridge, California, United States, 91325
Lucita M. Cruz,Md.,Inc.
Norwalk, California, United States, 90650
Sds Clinical Trials
Orange, California, United States, 92868
Bayview Research Group, Llc
Paramount, California, United States, 90723
San Diego Managed Care Group
Poway, California, United States, 92064
Integrated Research Group, Inc.
Riverside, California, United States, 92506
Quality Control Research, Inc
Sacramento, California, United States, 95842
Wetlin Research Associates, Inc.
San Diego, California, United States, 92120
Crest Clinical Trials, Inc.
Santa Ana, California, United States, 92701
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, United States, 90404
Neurological Research Institute
Santa Monica, California, United States, 90404
Torrance Clinical Research
Torrance, California, United States, 90505
Orange County Research Center
Tustin, California, United States, 92780
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
United States, Connecticut
Chase Medical Research, Llc
Waterbury, Connecticut, United States, 06708
United States, Delaware
Christiana Care Health Services, Inc
Newark, Delaware, United States, 19713
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Zasa Clinical Research
Boynton Beach, Florida, United States, 33472
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Innovative Research Of West Florida, Inc
Clearwater, Florida, United States, 33756
Clinical Research Of South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, Llc
Deland, Florida, United States, 32720
International Research Associates, Llc
Hialeah, Florida, United States, 33012
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
The Community Research Of South Florida
Hialeah, Florida, United States, 33016
Central Florida Internists
Kissimmee, Florida, United States, 34741
Pharmax Research Clinic, Inc.
Miami, Florida, United States, 33126
Baptist Diabetes Associates, Pa
Miami, Florida, United States, 33156
Clinical Research Of Miami, Inc.
Miami, Florida, United States, 33126
Apf Research, Llc
Miami, Florida, United States, 33135
Flcri Global Research, Llc
Miami, Florida, United States, 33125
Community Research Foundation, Inc.
Miami, Florida, United States, 33155
Newphase Clinical Trials, Inc.
Miami Beach, Florida, United States, 33140
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States, 33166
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Florida Institute For Clinical Research, Llc
Orlando, Florida, United States, 32822
Michele A. Morrison Internal Medicine, Inc.
Pembroke Pines, Florida, United States, 33026
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Meridien Research
Tampa, Florida, United States, 33606
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Perimeter Institute For Clinical Research
Atlanta, Georgia, United States, 30338
Bainbridge Medical Associates
Bainbridge, Georgia, United States, 39819
River Birch Research Alliance, Llc
Blue Ridge, Georgia, United States, 30513
In-Quest Medical Research, Llc
Duluth, Georgia, United States, 30096
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States, 31069
United States, Illinois
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
O?Fallon, Illinois, United States, 62269
Springfield Diabetes And Endocrine Center
Springfield, Illinois, United States, 62704
United States, Indiana
American Health Network Of Indiana Llc
Avon, Indiana, United States, 46123
Investigators Research Group, Llc
Brownsburg, Indiana, United States, 46112
American Health Network Of In Llc
Franklin, Indiana, United States, 46131
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Michigan City, Indiana, United States, 46360
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Muncie, Indiana, United States, 47304
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Medical Development Centers, Llc
Baton Rouge, Louisiana, United States, 70808
Omega Clinical Research, Llc
Metairie, Louisiana, United States, 70006
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Acadia Clinical Research, Llc
Bangor, Maine, United States, 04401
United States, Maryland
Alternative Primary Care
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, United States, 02740
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
Atlantic Clinical Trials, Llc
Watertown, Massachusetts, United States, 02472
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Providence Park Clinical Research
Novi, Michigan, United States, 48374
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The Center For Clinical Trials
Biloxi, Mississippi, United States, 39531
Phillips Medical Services, Pllc
Jackson, Mississippi, United States, 39209
United States, Missouri
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
Kcumb Dybedal Clinical Research Center
Kansas City, Missouri, United States, 64106
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Clin Research Advantage, Inc. James Meli, Do Family Pracice
Henderson, Nevada, United States, 89014
Independent Clinical Researchers@ Wolfson Medical Center
Las Vegas, Nevada, United States, 89103
Office Of Ted Thorp, Md
Las Vegas, Nevada, United States, 89102
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States, 89128
Palm Medical Research Center
Las Vegas, Nevada, United States, 89148
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Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Premier Research
Trenton, New Jersey, United States, 08611
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Medex Healthcare Research, Inc.
New York, New York, United States, 10022
Digiovanna Institute For Medical Education & Research
North Massapequa, New York, United States, 11758
Southgate Medical Group
West Seneca, New York, United States, 14224
United States, North Carolina
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States, 28557
Burke Primary Care
Morganton, North Carolina, United States, 28655
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Fargo, North Dakota, United States, 58103
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Community Health Care, Inc.
Canal Fulton, Ohio, United States, 44614
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Yukon, Oklahoma, United States, 73099
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Willamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
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Southeastern Pa Medical Institute
Broomall, Pennsylvania, United States, 19008
Abington Memorial Hos/Feasterville Family Health Care Center
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The Clinical Trial Center, Llc
Jenkintown, Pennsylvania, United States, 19046
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, United States, 19146
Arcuri Clinical Research Llc
Philadelphia, Pennsylvania, United States, 19142
Research Across America
Reading, Pennsylvania, United States, 19606
Pish Medical Associates
Uniontown, Pennsylvania, United States, 15401
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Greater Providence Clinical Research, Llc
Warwick, Rhode Island, United States, 02888
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Medical Research South
Charleston, South Carolina, United States, 29407
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States, 29605
North Myrtle Beach Family Practice
North Myrtle Beach, South Carolina, United States, 29582
Pawleys Pediatrics And Adult Medicine
Pawleys Island, South Carolina, United States, 29585
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, United States, 29681
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
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Southwind Medical Specialists
Memphis, Tennessee, United States, 38125
Tn Medical Research
Spring Hill, Tennessee, United States, 37174
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Arlington Family Research Center, Inc.
Arlington, Texas, United States, 76012
3rd Coast Research Associates
Corpus Christi, Texas, United States, 78414
Krk Medical Research
Dallas, Texas, United States, 75230
Internal Medicine Clinical Reaseach
Dallas, Texas, United States, 75235
Research Institute Of Dallas
Dallas, Texas, United States, 75231
Renaissance Clinical Research And Hypertension Pllc
Dallas, Texas, United States, 75235
Sergio F. Rovner, M.D.
El Paso, Texas, United States, 79925
Excel Clinical Research, Llc
Houston, Texas, United States, 77081
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77008
Dependable Clinical Research, Llc
Houston, Texas, United States, 77074
Southwest Clinical Trials
Houston, Texas, United States, 77074
Village Family Practice
Houston, Texas, United States, 77024
Bellaire Medical Care Group
Houston, Texas, United States, 77081
Hill Country Medical Associates
New Braunfels, Texas, United States, 78130
North Hills Medical Research, Inc.
North Richland Hills, Texas, United States, 76180
Med-Olam Clinical Research
Pasadena, Texas, United States, 77504
Lisa E. Medwedeff, Md, Pa
Plano, Texas, United States, 75024
Covenant Clinical Research, Pa
San Antonio, Texas, United States, 78229
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Sun Research Institute
San Antonio, Texas, United States, 78215
Abbott Clinical Research Group, Inc.
San Antonio, Texas, United States, 78224
Breco Research, Ltd
Sugarland, Texas, United States, 77479
United States, Utah
Exodus Healthcare Network
Magna, Utah, United States, 84044
Wasatch Endocrinology And Diabetes Specialists
Salt Lake City, Utah, United States, 84102
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Alexandria Health Care Center
Alexandria, Virginia, United States, 22314
Millennium Clinical Trials Llc
Arlington, Virginia, United States, 22203
Burke Internal Medicine And Research
Burke, Virginia, United States, 22015
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, United States, 23435
United States, Washington
Larry D. Stonesifer, Md
Federal Way, Washington, United States, 98003
Sound Medical Research
Port Orchard, Washington, United States, 98366
United States, Wisconsin
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States, 53142
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
Australia, Victoria
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Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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Kelowona, British Columbia, Canada, V1Y 3G8
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Victoria, British Columbia, Canada, V8V 3N7
Canada, New Brunswick
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Monction, New Brunswick, Canada, E1G 1A7
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Brampton, Ontario, Canada, L6T 3J1
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Granby, Quebec, Canada, J2G 8Z9
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Montreal, Quebec, Canada, H2R 1V6
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 3H3
Colombia
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Armenia, Quindio, Colombia, 0000
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Bucaramanga, Santander, Colombia, 0000
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Barranquilla, Colombia, -----
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Barranquilla, Colombia, 0000
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Bogota, Colombia, 0000
Czech Republic
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Beroun, Czech Republic, 266 01
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Cheb, Czech Republic, 350 02
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Havirov, Czech Republic, 736 01
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Krnov, Czech Republic, 794 01
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Liberec, Czech Republic, 460 01
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Ostrava, Czech Republic, 702 00
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Prague 1, Czech Republic, 116 94
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Praha 4, Czech Republic, 149 00
Denmark
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Copenhagen, Denmark, DK 2400
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Frederiksberg, Denmark, 2000
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Gentofte, Denmark, 2820
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Slagelse, Denmark, 4200
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Helsinki, Finland, 09200
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Kerava, Finland, 04200
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Kokkola, Finland, 67100
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Oulu, Finland, 90100
Germany
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Aschaffenburg, Bavaria, Germany, 63739
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Augsburg, Bavaria, Germany, 86150
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Duisburg, Nordrhein-Westfalen, Germany, 47051
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Bad Kreuznach, Germany, 55545
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Berlin, Germany, 10787
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Dortmund, Germany, 44137
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Dresden, Germany, 01307
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Karlsruhe, Germany, 76199
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Kothen, Germany, 06366
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Kronshagen, Germany, 24119
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Langenfeld, Germany, 40764
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Lueneburg, Germany, 21339
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Magdeburg, Germany, 39112
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Mainz, Germany, 55116
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Mannheim, Germany, 68161
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Saarbruecken, Germany, 66121
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Wuestensachsen, Germany, 36115
Hungary
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Gyongyos, Heves, Hungary, 3200
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Budapest, Hungary, H-1171
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Budapest, Hungary, 1134
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Eger, Hungary, 3300
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Kisvarda, Hungary, 4600
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Miskolc, Hungary, 3530
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Nyiregyhaza, Hungary, 4400
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Satoraljaujhely, Hungary, 3980
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Sopron, Hungary, 9400
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Szeged, Hungary, 6720
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Szekszard, Hungary, H-7100
India
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Hyderabad, Andhra Pradesh, India, 5000 18
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Bangalore, Karnataka, India, 560043
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Bangalore, Karnataka, India, 560092
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Bangalore, Karnataka, India, 560 043
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Mangalore, Karnataka, India, 575001
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Belgaum, Karnatka, India, 590010
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Indore, Madhya Pradesh, India, 452010
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Nagpur, Maharashtra, India, 440033
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Nagpur, Maharashtra, India, 440010
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Nagpur, Maharashtra, India, 440012
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Delhi, New Delhi, India, 110007
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Jaipur, Rajasthan, India, 202023
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Chennai, Tamil Nadu, India, 600013
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Coimbatore, Tamil Nadu, India, 641 018
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Madurai, Tamilnadu, India, 625020
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Chennai Tamilnadu, India, 6000081
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Hyderabad, India, 500063
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Nagpur, India, 440012
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Trivandrum, India, 695011
Ireland
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Dublin 15, Dublin, Ireland
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Galway, Ireland
Mexico
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Torreon, Coahuila, Mexico, 27000
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Mexico City, Distrito Federal, Mexico, 03300
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Mexico City, Distrito Federal, Mexico, 07760
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Guadalajara, Jalisco, Mexico, 44100
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Guadalajara, Jalisco, Mexico, 44130
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Guadalajara, Jalisco, Mexico, 44670
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Cuautla, Morelos, Mexico, 62744
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Monterrey, Nuevo Leon, Mexico, 64460
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Monterrey, Nuevo Leon, Mexico, 64000
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Culiacan, Sinaloa, Mexico, 80020
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Merida, Yucatan, Mexico, 97070
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Chihuahua, Mexico, 31217
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Del. Benito Juarez, Mexico, 03100
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Delegacion Tlalpan, Mexico, 14000
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Distrito Federal, Mexico, 07020
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San Luis Potosi, Mexico, 78200
Poland
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Bialystok, Poland, 15-404
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Bialystok, Poland, 15-879
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Chrzanow, Poland, 32-500
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Elblag, Poland, 82-300
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Gdansk, Poland, 80-847
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Gdynia, Poland, 81-384
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Kamieniec Zabkowicki, Poland, 57-230
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Katowice, Poland, 40-748
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Kielce, Poland, 25-364
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Krakow, Poland, 30-015
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Krakow, Poland, 31-159
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Lodz, Poland, 92-525
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Lodz, Poland, 90-242
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Lublin, Poland, 20-044
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Ostroda, Poland, 14-100
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Poznan, Poland, 61-251
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Warsaw, Poland, 02-507
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Warsaw, Poland, 02-097
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Warszawa, Poland, 01-337
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Warszawa, Poland, 01-192
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Warszawa, Poland, 01-868
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Wroclaw, Poland, 50-088
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Wroclaw, Poland, 50-349
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Zabrze, Poland, 41-800
Puerto Rico
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Fajard, Puerto Rico, 00738
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Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00920
Romania
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Oradea, Bihor, Romania, 410169
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Oradea, Jud. Bihor, Romania, 410469
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Timisoara, Jud. Timis, Romania, 300125
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Targu Mures, Mures, Romania, 540142
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Targu Mures, Mures, Romania, 540098
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Ploiesti, Prahova, Romania, 100342
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Ploiesti, Prahova, Romania, 100163
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Timisoara, Timis, Romania, 300456
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Bucuresti, Romania, 010719
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Bucuresti, Romania, 020475
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Bucuresti, Romania, 020725
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Bucuresti, Romania, 010507
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Cluj-Napoca, Romania, 400006
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Satu Mare, Romania, 440055
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Sibiu, Romania, 550371
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Sibiu, Romania, 550245
United Kingdom
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Irvine, Ayrshire, United Kingdom, KA11 1JU
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Ely, Cambridgeshire, United Kingdom, CB7 5JD
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Birmingham, West Midlands, United Kingdom, B9 5SS
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Bath, Wiltshire, United Kingdom, BA2 3HT
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01195662     History of Changes
Other Study ID Numbers: MB102-077, 2010-019798-13
Study First Received: September 3, 2010
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Secretaria de Salud
Australia: Department of Health and Ageing Therapeutic Goods Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: The Ministry of the Interior and Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014