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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of cardiovascular events per patient per year

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
Hoffmann-La Roche

909 total trials

What the finished NCT00658515 record still lists

NCT00658515 is an interventional study that assigns participants to a tested intervention. Its 15,871 participants enrollment target places it among the larger protocols in the corpus, above the 653-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (2330% higher).

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 names 20 study sites across 3 states, led by 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.

Where NCT00658515's enrollment target sits among peer trials

15,871 1st of 19 higher than 19 of 19 other Coronary Heart Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Heart Disease 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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Related registry views

Source: ClinicalTrials.gov NCT00658515, the US trial registry maintained by the National Library of Medicine. NCT00658515 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.