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
1 other identifier
interventional
292
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
Shorter than P25 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedResults Posted
Study results publicly available
January 2, 2020
CompletedJanuary 2, 2020
December 1, 2019
10 months
June 11, 2008
July 17, 2019
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Absolute Change From Baseline in HDL-C Level\n
Week 12
Percent Change From Baseline in HDL-C Level\n
12 Weeks
Secondary Outcomes (4)
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
Study Arms (4)
Dalcetrapib 300mg
EXPERIMENTALDalcetrapib 600mg
EXPERIMENTALDalcetrapib 900mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients 18-75 years of age;
- dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Newark, Delaware, 19713, United States
Unknown Facility
Miami, Florida, 33137, United States
Unknown Facility
Chicago, Illinois, 60610-4319, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Overland Park, Kansas, 66215, United States
Unknown Facility
Wichita, Kansas, 67207, United States
Unknown Facility
Louisville, Kentucky, 40213, United States
Unknown Facility
Chalmette, Louisiana, 70043, United States
Unknown Facility
Slidell, Louisiana, 70458, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Bethesda, Maryland, 20817, United States
Unknown Facility
Towson, Maryland, 21204, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Concord, New Hampshire, 03301, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Springdale, Ohio, 45246, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Warminster, Pennsylvania, 18974, United States
Unknown Facility
Fort Worth, Texas, 76107, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
July 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
January 2, 2020
Results First Posted
January 2, 2020
Record last verified: 2019-12