A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

Roche

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Pravastatin; Drug: Placebo; Drug: Dalcetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697203

NC18589

Details and patient eligibility

About

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Enrollment: 292 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 18-75 years of age;
• dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Exclusion criteria

• women who are pregnant, breastfeeding, or of child-bearing potential;
• morbid obesity;
• uncontrolled hypertension;
• poorly controlled or insulin-treated diabetes;
• high creatinine levels or history of statin-associated myopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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292 participants in 4 patient groups, including a placebo group

Dalcetrapib 300mg

Experimental group

Treatment:

Drug: Dalcetrapib

Drug: Pravastatin

Drug: Dalcetrapib

Drug: Dalcetrapib

Dalcetrapib 600mg

Experimental group

Treatment:

Drug: Dalcetrapib

Drug: Pravastatin

Drug: Dalcetrapib

Drug: Dalcetrapib

Dalcetrapib 900mg

Experimental group

Treatment:

Drug: Dalcetrapib

Drug: Pravastatin

Drug: Dalcetrapib

Drug: Dalcetrapib

Placebo

Placebo Comparator group

Treatment:

Drug: Pravastatin

Drug: Placebo