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NCT00655473 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Coronary Heart Disease, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
130
Enrollment target
12
Study locations

NCT00655473 is a Phase 2 study of Coronary Heart Disease that has completed, run by Hoffmann-La Roche. The registered enrollment target is 130 participants, below the 1,481-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (91% lower). The trial reports 12 study locations across 10 states.

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The verdict

NCT00655473, a Phase 2 study of Coronary Heart Disease, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
130 participants
Enrollment target
12
Study locations

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

Coronary Heart Disease

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

909 total trials

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What the Registry Record Tells You About NCT00655473

The ClinicalTrials.gov registry entry for NCT00655473 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,481-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (91% lower). 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 2 interventions - of which Placebo is the first listed.

NCT00655473 reports 12 study locations spanning 10 distinct geographic areas - top geographies include Ohio, Florida, Michigan.

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.

What interventions are being tested in trial NCT00655473?

The interventions under investigation include: Placebo (DRUG), Dalcetrapib (RO4607381) (DRUG).

Who is sponsoring clinical trial NCT00655473?

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

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.

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

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.