A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655473
• Other study ID #: NC21153
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: November 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 effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2010
• Est. primary completion date: November 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, including patients with other CHD risk factors;

• treated appropriately for dyslipidemia;

• clinically stable.

Exclusion Criteria:

• previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;

• recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;

• severe anemia;

• uncontrolled hypertension;

• poorly controlled diabetes.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Drug:
• Dalcetrapib (RO4607381)
600mg po daily for 24 months
• Placebo
po daily for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Mean Wall Thickness		24 months
Primary	Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.		6 months
Secondary	Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance		6 months
Secondary	Change From Baseline in Vessel MR Determined Plaque Anatomy		Up to 24 months
Secondary	Blood Lipids,Lipoproteins		Throughout study
Secondary	Biomarkers		Up to 24 months
Secondary	CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure		Throughout study