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COMPLETED Phase 3

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

NCT00658515 · View on ClinicalTrials.gov ↗

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

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

758 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15,871 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00658515 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Arizona, Alabama, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00658515?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial