A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

January 24, 2020 updated by: Hoffmann-La Roche

A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

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

  • Germany
      • Berlin, Germany, 10707
      • Bochum, Germany, 06097
      • Dortmund, Germany, 44137
      • Erlangen, Germany, 91054
      • Freiburg, Germany, 79106
      • Hamburg, Germany, 20249
      • München, Germany, 80336
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Maryland
      • Bethesda, Maryland, United States, 20817
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • North Carolina
      • Statesville, North Carolina, United States, 28677
    • Ohio
      • Cincinnati, Ohio, United States, 45212
      • Cincinnati, Ohio, United States, 45219
    • Utah
      • Salt Lake City, Utah, United States, 84132

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 or CHD risk equivalent;
  • body weight <125kg at visit 1.

Exclusion Criteria:

  • recent (within 3 weeks of screening) clinically significant coronary events;
  • history of statin-associated myopathy, or intolerance to statin;
  • history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
  • exposure to RO4607381 in past 12 months.

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
Experimental: Dalcetrapib
Dalcetrapib 900mg po daily for 24 weeks
Drug: dalcetrapib
900mg po daily for 24 weeks
Placebo Comparator: Placebo
Placebo po daily for 24 weeks
Drug: Placebo
po daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute Change From Baseline in HDL-C
Time Frame: Baseline and Week 24
Baseline and Week 24
Percent Change From Baseline in HDL-C
Time Frame: Baseline and Week 24
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass
Time Frame: Baseline and Weeks 24
Baseline and Weeks 24
Change in Mesenteric Lymph Nodes
Time Frame: Baseline and 48 Weeks
Baseline and 48 Weeks
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
Time Frame: Baseline and 48 Weeks
Baseline and 48 Weeks
Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity
Time Frame: Baseline and 48 Weeks
Baseline and 48 Weeks

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

July 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC19453

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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