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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

NCT01195662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2245

Last updated 2016-12-29

Study results available
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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

Conditions

Interventions

DRUG

Dapagliflozin

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

DRUG

Placebo matching Dapagliflozin

Tablets, Oral, 0 mg, once daily, 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
2010-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Australia
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • India
  • Ireland
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • United Kingdom

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 NCT01195662 on ClinicalTrials.gov