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A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

NCT01137474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2996

Last updated 2017-01-26

Study results available
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Summary

The purpose of this study is to learn whether 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 or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Dapagliflozin

Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks

DRUG

Placebo-matching dapagliflozin

Oral tablets administered as 0 mg once daily for up to 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • India
  • Mexico
  • Peru
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137474 on ClinicalTrials.gov