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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: dalcetrapib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib<br> | Drug: dalcetrapib<br>* 600mg po daily for 36 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po daily for 36 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in % FMD |  | baseline and 36 weeks | 
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB |  | Baseline to 36 weeks | 
| CETP Activity |  | 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 |  | Baseline and 36 weeks | 
| Change From Baseline in Mean BP, Measured by BP Monitoring |  | Up to 36 weeks | 
| Percent Change CETP Mass |  | baseline to 36 weeks |