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

Roche

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: dalcetrapib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353522

NC19453

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

Dalcetrapib

Experimental group

Description:

Dalcetrapib 900mg po daily for 24 weeks

Treatment:

Drug: dalcetrapib

Placebo

Placebo Comparator group

Description:

Placebo po daily for 24 weeks

Treatment:

Drug: Placebo