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NCT01609582 · ClinicalTrials.gov registry record · Phase 3
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3,207
- Enrollment target
NCT01609582: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01609582 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 3,207 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (315% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609582, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3,207 participants
- Enrollment target
Study 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.
Primary Outcome
The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
Interventions
- DRUG TAK-875
- DRUG TAK-875 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,207 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
Why NCT01609582 stopped before completion
NCT01609582 is an interventional study that assigns participants to a tested intervention. Its 3,207 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (315% higher).
The record links to 0 conditions, and to 2 interventions - of which TAK-875 is the first listed.
NCT01609582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01609582 about?
NCT01609582 is a clinical study titled "Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease". 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.
What is the current status of trial NCT01609582?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3,207 participants. The study started on 2012-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01609582?
The interventions under investigation include: TAK-875 (DRUG), TAK-875 Placebo (DRUG).
Who is sponsoring clinical trial NCT01609582?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01609582's enrollment target sits among peer trials
3,207 73rd of 2000 higher than 1,928 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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