CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,245 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01195662
NCT01195662Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Sep 6, 2010·Updated Dec 29, 2016

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Placebo matching Dapagliflozin for Type 2 Diabetes. Completed, enrolled 2,245 participants across 298 sites in 16 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesAustralia, Canada, Colombia, Czechia, Denmark, Finland, Germany, Hungary, India, Ireland, Mexico, Poland, Puerto Rico, Romania, United Kingdom, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 6, 2010
Enrollment StartOct 1, 2010
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago

Interventions

Dapagliflozindrug

Tablets, Oral, 10 mg, once daily, Up to 12 weeks

Placebo matching Dapagliflozindrug

Tablets, Oral, 0 mg, once daily, Up to 12 weeks