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

Hoffmann-La Roche292 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

292

Conditions

Dyslipidemia

Interventions

PlaceboDRUG

po daily for 12 weeks

PravastatinDRUG

40mg po daily for 12 weeks

DalcetrapibDRUG

300mg po daily for 12 weeks

Dalcetrapib

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (33)

Unnamed facility

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Absolute Change From Baseline in HDL-C Level\n

Time frame: Week 12

Percent Change From Baseline in HDL-C Level\n

Time frame: 12 Weeks

Secondary Outcomes

Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI

Time frame: 12 weeks

Percent Change of Fasting Glucose Level

Time frame: 12 weeks

AEs, Lab Parameters, Vital Signs, ECG

Time frame: Through 9 Months

Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB

Time frame: Baseline and at 12 Weeks

Data from ClinicalTrials.gov

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