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
Study identifier:MB102-077 ST
ClinicalTrials.gov identifier:NCT01195662
EudraCT identifier:2010-019798-13
CTIS identifier:N/A
Study Complete
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
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, Placebo matching Dapagliflozin
Sex
All
Actual Enrollment
2245
Study type
Interventional
Age
18 Years - 89 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Feb 2013
Study Completion Date: 01 Feb 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin 10 mg Dapagliflozin 10 mg tablets | Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, Up to 12 weeks Other Name: BMS-512148 Other Name: Farxiga™ |
| Placebo Comparator: Placebo matching Dapagliflozin Placebo tablets matching dapagliflozin tablets | Drug: Placebo matching Dapagliflozin Tablets, Oral, 0 mg, once daily, Up to 12 weeks |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
