Official 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”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: RO4607381
  • 300mg po daily for 12 weeks
• Drug: RO4607381
  • 600mg po daily for 12 weeks
• Drug: RO4607381
  • 900mg po daily for 12 weeks
• Drug: Placebo
  • po daily for 12 weeks
• Drug: Pravastatin
  • 40mg po daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Placebo Comparator: 4

Primary Measures

• Percentage and absolute change from baseline in HDL-C level
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• Fasting glucose and insulin levels
  • Time Frame: 12 week period of double-blind treatment
    Safety Issue?: No
• AEs, lab parameters, vital signs, ECG
  • Time Frame: Throughout study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00697203

Study ID Number: NC18589

ClinicalTrials.gov Identifier: NCT00697203

Health Authority: United States: Food and Drug Administration