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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00655538

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: RO4607381 Drug: Placebo	Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	540
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2011

Arms	Assigned Interventions
1: Experimental	Drug: RO4607381 600mg po daily for 36 weeks
2: Placebo Comparator	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

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

Contacts

Contact: Please reference Study ID Number: BC21144	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Austria
	Recruiting
FELDKIRCH, Austria, 6800
France
	Recruiting
Paris, France, 75674
Germany
	Recruiting
DORTMUND, Germany, 44137
	Recruiting
Wuppertal, Germany, 42117
	Recruiting
MAINZ, Germany, 55101
	Recruiting
Frankfurt, Germany, 60590
	Recruiting
Bonn, Germany, 53105
Italy
	Recruiting
PISA, Italy, 56100
Netherlands
	Recruiting
AMSTERDAM, Netherlands, 1105 AZ
	Recruiting
Utrecht, Netherlands, 3584 CX
	Recruiting
Hoorn, Netherlands, 1625 HV
	Recruiting
Zoetermeer, Netherlands, 2724 EK
	Recruiting
Rotterdam, Netherlands, 3021 HC
	Recruiting
Nijmegen, Netherlands, 6533 HL
	Recruiting
Leiden, Netherlands, 2311 GZ
	Recruiting
Eindhoven, Netherlands, 5611 NJ
	Recruiting
Breda, Netherlands, 4811 VL
	Recruiting
Groningen, Netherlands, 9711 SG
	Recruiting
Velp, Netherlands, 6883 ES
	Recruiting
GOES, Netherlands, 4462 RA
Switzerland
	Recruiting
Zurich, Switzerland, 8091
	Recruiting
Lugano, Switzerland, 6900
United Kingdom
	Not yet recruiting
CARDIFF, United Kingdom, CF14 4XN

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BC21144, 2007-003406-10
Study First Received:	March 28, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00655538
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Dilatation, Pathologic
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009