A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

NCT ID: NCT00353522

Last Updated: 2020-01-27

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

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-31

Brief Summary

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This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Coronary Heart Disease

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

Dalcetrapib 900mg po daily for 24 weeks

Group Type EXPERIMENTAL

dalcetrapib

Intervention Type DRUG

900mg po daily for 24 weeks

Placebo

Placebo po daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po daily for 24 weeks

Interventions

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Placebo

po daily for 24 weeks

Intervention Type DRUG

dalcetrapib

900mg po daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* CHD or CHD risk equivalent;
* body weight \<125kg at visit 1.

Exclusion Criteria

* recent (within 3 weeks of screening) clinically significant coronary events;
* history of statin-associated myopathy, or intolerance to statin;
* history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
* exposure to RO4607381 in past 12 months.
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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Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Iowa City, Iowa, United States

Site Status

Louisville, Kentucky, United States

Site Status

Bethesda, Maryland, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Statesville, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Dortmund, , Germany

Site Status

Erlangen, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Hamburg, , Germany

Site Status

München, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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NC19453

Identifier Type: -

Identifier Source: org_study_id

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