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

NCT ID: NCT00697203

Last Updated: 2020-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-05-31

Brief Summary

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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

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dalcetrapib 300mg

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

40mg po daily for 12 weeks

Dalcetrapib

Intervention Type DRUG

300mg po daily for 12 weeks

Dalcetrapib 600mg

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

40mg po daily for 12 weeks

Dalcetrapib

Intervention Type DRUG

600mg po daily for 12 weeks

Dalcetrapib 900mg

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

40mg po daily for 12 weeks

Dalcetrapib

Intervention Type DRUG

900mg po daily for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po daily for 12 weeks

Pravastatin

Intervention Type DRUG

40mg po daily for 12 weeks

Interventions

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Placebo

po daily for 12 weeks

Intervention Type DRUG

Pravastatin

40mg po daily for 12 weeks

Intervention Type DRUG

Dalcetrapib

300mg po daily for 12 weeks

Intervention Type DRUG

Dalcetrapib

600mg po daily for 12 weeks

Intervention Type DRUG

Dalcetrapib

900mg po daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Mobile, Alabama, United States

Site Status

Scottsdale, Arizona, United States

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Newark, Delaware, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Chalmette, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Towson, Maryland, United States

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St Louis, Missouri, United States

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Concord, New Hampshire, United States

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Charlotte, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Springdale, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NC18589

Identifier Type: -

Identifier Source: org_study_id

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