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

Coronary Heart Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655538
• Other study ID #: BC21144
• Secondary ID: 2007-003406-10
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Placebo
po daily for 36 weeks
• dalcetrapib
600mg po daily for 36 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in % Flow Mediated Dilatation (FMD)		Baseline and 12 weeks
Primary	Change From Baseline in Mean BP, Measured by BP Monitoring		Baseline and 4 weeks
Secondary	Change From Baseline in % FMD		baseline and 36 weeks
Secondary	Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB		Baseline to 36 weeks
Secondary	CETP Activity		Up to 36 weeks
Secondary	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		Baseline and 36 weeks
Secondary	Change From Baseline in Mean BP, Measured by BP Monitoring		Up to 36 weeks
Secondary	Percent Change CETP Mass		baseline to 36 weeks