Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

NCT01609582 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3207

Last updated 2015-10-19

Study results available
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Summary

The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

Conditions

Interventions

DRUG

TAK-875

TAK-875 tablets

DRUG

TAK-875 Placebo

TAK-875 placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Sr. Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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Entities

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 NCT01609582 on ClinicalTrials.gov