Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00658515 · ClinicalTrials.gov registry record · Phase 3

A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

A Phase 3 study of Coronary Heart Disease, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
15,871
Enrollment target
20
Study locations

NCT00658515 is a Phase 3 study of Coronary Heart Disease that has completed, run by Hoffmann-La Roche. The registered enrollment target is 15,871 participants, above the 653-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (2330% higher). The trial reports 20 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00658515, a Phase 3 study of Coronary Heart Disease, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
15,871 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Conditions Studied

Coronary Heart Disease

Interventions

  • DRUG Placebo
  • DRUG Dalcetrapib (RO4607381)
  • DRUG Evidence-based medical care for Acute Coronary Syndrome

Study Locations (20)

Arizona

  • - Lake Havasu City
  • - Mesa
  • - Phoenix
  • - Phoenix
  • - Scottsdale
  • - Scottsdale
  • - Sierra Vista
  • - Tempe
  • - Tucson

Alabama

  • - Birmingham
  • - Birmingham
  • - Birmingham
  • - Birmingham
  • - Mobile
  • - Tuscaloosa

Arkansas

  • - Hot Springs
  • - Jonesboro
  • - Little Rock
  • - Mountain Home
  • - Searcy

Trial Details

FieldValue
Enrollment Target 15,871 participants
Start Date 2008-04
Est. Completion 2012-09
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00658515

The ClinicalTrials.gov registry entry for NCT00658515 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15,871 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 653-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (2330% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Heart Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00658515 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Alabama, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00658515 about?

NCT00658515 is a clinical study titled "A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome". This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to ...

What is the current status of trial NCT00658515?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15,871 participants. The study started on 2008-04. Estimated completion is 2012-09.

What conditions does trial NCT00658515 study?

This clinical trial studies the following conditions: Coronary Heart Disease.

What interventions are being tested in trial NCT00658515?

The interventions under investigation include: Placebo (DRUG), Dalcetrapib (RO4607381) (DRUG), Evidence-based medical care for Acute Coronary Syndrome (DRUG).

Who is sponsoring clinical trial NCT00658515?

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

Where is trial NCT00658515 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Coronary Heart Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Coronary Heart Disease

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.