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COMPLETED Phase 2

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

NCT00655473 · View on ClinicalTrials.gov ↗

Study Summary

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dalcetrapib (RO4607381)

Study Locations (12)

Ohio

  • — Cincinnati
  • — Cincinnati
  • — Cleveland

Florida

  • — Jacksonville

Michigan

  • — Royal Oak

Minnesota

  • — Minneapolis

Missouri

  • — Kansas City

New York

  • — New York

North Carolina

  • — Statesville

Texas

  • — Houston

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2008-03
Est. Completion 2010-11
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00655473

The ClinicalTrials.gov registry entry for NCT00655473 describes a study currently listed as completed. It is categorized as Phase 2, 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 130 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 2 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: NCT00655473 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Ohio, Florida, Michigan. 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 NCT00655473 about?

NCT00655473 is a clinical study titled "A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease". This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI...

What is the current status of trial NCT00655473?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2008-03. Estimated completion is 2010-11.

What conditions does trial NCT00655473 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 NCT00655473?

The interventions under investigation include: Placebo (DRUG), Dalcetrapib (RO4607381) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00655473?

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 NCT00655473 being conducted?

This trial has 12 study locations across Florida, Michigan, Minnesota, Missouri, New York. 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