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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:
ClinicalTrials.gov Identifier:
NCT00655538
First Posted: April 10, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Change from baseline in % FMD [ Time Frame: 36 weeks ]
  • Blood lipids, lipoproteins [ Time Frame: Throughout study ]
  • CETP mass and activity [ Time Frame: Up to 36 weeks ]
  • Biomarkers [ Time Frame: Up to 36 weeks ]
  • Change from baseline in mean BP, measured by BP monitoring [ Time Frame: Up to 36 weeks ]
  • AEs, lab parameters, vital signs, ECG [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 3508 GA
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

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
First Submitted: March 28, 2008
First Posted: April 10, 2008
Last Update Posted: November 2, 2016
Last Verified: November 2016

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