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NCT01042769 · ClinicalTrials.gov registry record · Phase 3

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
7,226
Enrollment target

NCT01042769 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 7,226 participants.

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The verdict

NCT01042769, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
7,226 participants
Enrollment target

Study Summary

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Interventions

  • DRUG Placebo
  • DRUG Aleglitazar

Trial Details

FieldValue
Enrollment Target 7,226 participants
Start Date 2010-02
Est. Completion 2013-11
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01042769

The ClinicalTrials.gov registry entry for NCT01042769 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01042769 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01042769 about?

NCT01042769 is a clinical study titled "A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus". This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients ...

What is the current status of trial NCT01042769?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,226 participants. The study started on 2010-02. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01042769?

The interventions under investigation include: Placebo (DRUG), Aleglitazar (DRUG).

Who is sponsoring clinical trial NCT01042769?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.