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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00655538
First received: March 28, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will assess the safety, tolerability and efficacy of RO4607381 in pat ients with coronary heart disease (CHD) or CHD risk equivalents. Patients will b e randomized to receive either RO4607381 600mg po daily or placebo po daily. End othelial function will be measured by flow mediated dilatation and blood pressur e 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.


Condition Intervention Phase
Coronary Heart Disease
Drug: dalcetrapib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from baseline in % flow mediated dilatation (FMD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in % FMD [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Blood lipids, lipoproteins [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • CETP mass and activity [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • AEs, lab parameters, vital signs, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 476
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
600mg po daily for 36 weeks
Placebo Comparator: 2 Drug: Placebo
po daily for 36 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655538

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
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, 3584 CX
Velp, Netherlands, 6883 ES
Zoetermeer, Netherlands, 2724 EK
Switzerland
Lugano, Switzerland, 6900
Zürich, Switzerland, 8091
United Kingdom
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00655538     History of Changes
Other Study ID Numbers: BC21144, 2007-003406-10
Study First Received: March 28, 2008
Last Updated: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014