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

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Placebo; Drug: Pravastatin; Drug: Dalcetrapib

• Registration Number: NCT00697203
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Results First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dalcetrapib 900mg	Dalcetrapib	-
Placebo	Placebo	-
Dalcetrapib 600mg	Dalcetrapib	-
Dalcetrapib 300mg	Pravastatin	-
Dalcetrapib 300mg	Dalcetrapib	-
Dalcetrapib 600mg	Pravastatin	-
Dalcetrapib 900mg	Pravastatin	-
Placebo	Pravastatin	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in HDL-C Level\n	12 Weeks
Absolute Change From Baseline in HDL-C Level\n	Week 12

Secondary Outcome Measures

Name	Time	Method
AEs, Lab Parameters, Vital Signs, ECG	Through 9 Months
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI	12 weeks
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB	Baseline and at 12 Weeks
Percent Change of Fasting Glucose Level	12 weeks