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A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) - NCT01137474-27408(Clinical Trial 679953)



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City:  Greensboro
State:  
NC
Zip Code: 27408
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
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 (ACE) inhibitor or an Angiotensin Receptor Blocker (ARB). The safety of this treatment will also be studied.
Study summary:
Criteria: Inclusion Criteria: - Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-105. - Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB for 4 weeks - C-peptide ≥ .08 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: - AST and /or 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
Study is available at: Pharmquest
Greensboro, NC 27408
United States

Primary Contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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