A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

Coronary Heart Disease Clinical Trial

Official title:

A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353522
• Other study ID #: NC19453
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• 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;

• body weight <125kg at visit 1.

Exclusion Criteria:

• recent (within 3 weeks of screening) clinically significant coronary events;

• history of statin-associated myopathy, or intolerance to statin;

• history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;

• exposure to RO4607381 in past 12 months.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
po daily for 24 weeks
• dalcetrapib
900mg po daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in HDL-C		Baseline and Week 24
Primary	Percent Change From Baseline in HDL-C		Baseline and Week 24
Secondary	Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass		Baseline and Weeks 24
Secondary	Change in Mesenteric Lymph Nodes		Baseline and 48 Weeks
Secondary	Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)		Baseline and 48 Weeks
Secondary	Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity		Baseline and 48 Weeks