Trial Information

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

Status: Completed

Protocol Number: NC18589

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of RO4607381 in combination with pravastatin on HDL-cholesterol (HDL-C) levels in patients with low or average HDL-C levels

Brief Summary: 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. Target sample size is 240.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Dyslipidemia

Intervention Type: Drug

Intervention Name: RO4607381

Primary Outcome: 1. Percentage and absolute change from baseline in HDL-C level Time frame: Week 12

Key Secondary Outcomes: 1. Change from baseline in: TC, TG, HDL-C, LDL-C, HDL-2, HDL-3, ApoAI, ApoAII, ApoB, ApoE, LpAI, oxidized LDL, and ratios of these lipid parameters Time frame: 12 week period of double-blind treatment 2. Fasting glucose and insulin levels Time frame: 12 week period of double-blind treatment 3. AEs, lab parameters, vital signs, ECG Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:47:37 PM