View Clinical Trial (Medical Research Study)

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) - NCT01137474-29621(Clinical Trial 679962)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Anderson
State:  
SC
Zip Code: 29621
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: Southeastern Research Associates, Inc.
Anderson, SC 29621
United States

Primary Contact:
Carl W. Sofley Jr., Site 035
Phone: 864-512-5738

Secondary 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.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.