A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

December 13, 2019 updated by: Hoffmann-La Roche

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

476

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

  • Austria
      • Feldkirch, Austria, 6800
  • France
      • Paris, France, 75908
  • Germany
      • Bonn, Germany, 53127
      • Dortmund, Germany, 44137
      • Frankfurt, Germany, 60596
      • Mainz, Germany, 55131
      • Wuppertal, Germany, 42117
  • Italy
    • Toscana
      • Pisa, Toscana, Italy, 56100
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Breda, Netherlands, 4811 SW
      • Eindhoven, Netherlands, 5611 NJ
      • Goes, Netherlands, 4462 RA
      • Groningen, Netherlands, 9711 SG
      • Hoorn, Netherlands, 1625 HV
      • Leiderdorp, Netherlands, 2352 RA
      • Nijmegen, Netherlands, 6525 EC
      • Rotterdam, Netherlands, 3021 HC
      • Utrecht, Netherlands, 3508 GA
      • Velp, Netherlands, 6883 ES
      • Zoetermeer, Netherlands, 2724 EK
  • Switzerland
      • Lugano, Switzerland, 6900
      • Zürich, Switzerland, 8091
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN

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;
  • appropriately treated for accepted LDL-C level.

Exclusion Criteria:

  • treatment with drugs raising HDL-C (eg niacin, fibrates);
  • uncontrolled hypertension;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • 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 36 weeks
Experimental: Dalcetrapib
Drug: dalcetrapib
600mg po daily for 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in % Flow Mediated Dilatation (FMD)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in % FMD
Time Frame: baseline and 36 weeks
baseline and 36 weeks
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
CETP Activity
Time Frame: Up to 36 weeks
Up to 36 weeks
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Time Frame: Baseline and 36 weeks
Baseline and 36 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Time Frame: Up to 36 weeks
Up to 36 weeks
Percent Change CETP Mass
Time Frame: baseline to 36 weeks
baseline to 36 weeks

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

February 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC21144
  • 2007-003406-10

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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