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

December 16, 2019 updated by: Hoffmann-La Roche

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • Kansas City, Missouri, United States, 64111
    • New York
      • New York, New York, United States, 10029
    • North Carolina
      • Statesville, North Carolina, United States, 28677
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45227
      • Cleveland, Ohio, United States, 44195
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • CHD, including patients with other CHD risk factors;
  • treated appropriately for dyslipidemia;
  • clinically stable.

Exclusion Criteria:

  • previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • uncontrolled hypertension;
  • poorly controlled diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
po daily for 24 months
Experimental: Dalcetrapib (RO4607381)
Drug: Dalcetrapib (RO4607381)
600mg po daily for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Mean Wall Thickness
Time Frame: 24 months
24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Time Frame: 6 months
6 months
Change From Baseline in Vessel MR Determined Plaque Anatomy
Time Frame: Up to 24 months
Up to 24 months
Blood Lipids,Lipoproteins
Time Frame: Throughout study
Throughout study
Biomarkers
Time Frame: Up to 24 months
Up to 24 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC21153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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