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

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 Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Placebo; Drug: Pravastatin; Drug: Dalcetrapib; Drug: Dalcetrapib; Drug: Dalcetrapib

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Scottsdale, Arizona, United States, 85251
  • Delaware
    • Newark, Delaware, United States, 19713
  • Florida
    • Miami, Florida, United States, 33137
  • Illinois
    • Chicago, Illinois, United States, 60610-4319
  • Indiana
    • Evansville, Indiana, United States, 47714
    • Indianapolis, Indiana, United States, 46260
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kansas
    • Overland Park, Kansas, United States, 66215
    • Wichita, Kansas, United States, 67207
  • Kentucky
    • Louisville, Kentucky, United States, 40213
  • Louisiana
    • Chalmette, Louisiana, United States, 70043
    • Slidell, Louisiana, United States, 70458
  • Maine
    • Auburn, Maine, United States, 04210
    • Scarborough, Maine, United States, 04074
  • Maryland
    • Baltimore, Maryland, United States, 21201
    • Bethesda, Maryland, United States, 20817
    • Towson, Maryland, United States, 21204
  • Missouri
    • Saint Louis, Missouri, United States, 63110
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
    • Statesville, North Carolina, United States, 28677
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Cincinnati, Ohio, United States, 45212
    • Springdale, Ohio, United States, 45246
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
    • Warminster, Pennsylvania, United States, 18974
  • Texas
    • Fort Worth, Texas, United States, 76107
    • Houston, Texas, United States, 77030
  • Virginia
    • Richmond, Virginia, United States, 23294
  • Washington
    • Seattle, Washington, United States, 98104
  • Wisconsin
    • Madison, Wisconsin, United States, 53719

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; po daily for 12 weeks; Drug: Pravastatin; 40mg po daily for 12 weeks
Experimental: Dalcetrapib 300mg	Drug: Pravastatin; 40mg po daily for 12 weeks; Drug: Dalcetrapib; 300mg po daily for 12 weeks; Drug: Dalcetrapib; 600mg po daily for 12 weeks; Drug: Dalcetrapib; 900mg po daily for 12 weeks
Experimental: Dalcetrapib 600mg	Drug: Pravastatin; 40mg po daily for 12 weeks; Drug: Dalcetrapib; 300mg po daily for 12 weeks; Drug: Dalcetrapib; 600mg po daily for 12 weeks; Drug: Dalcetrapib; 900mg po daily for 12 weeks
Experimental: Dalcetrapib 900mg	Drug: Pravastatin; 40mg po daily for 12 weeks; Drug: Dalcetrapib; 300mg po daily for 12 weeks; Drug: Dalcetrapib; 600mg po daily for 12 weeks; Drug: Dalcetrapib; 900mg po daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute Change From Baseline in HDL-C Level\n	Week 12
Percent Change From Baseline in HDL-C Level\n	12 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 13, 2008

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin; Dalcetrapib
• Other Study ID Numbers: NC18589