A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
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ClinicalTrials.gov Identifier: NCT00353522 |
Recruitment Status
:
Completed
First Posted
: July 18, 2006
Last Update Posted
: November 2, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Drug: Placebo Drug: dalcetrapib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Dalcetrapib
Dalcetrapib 900mg po daily for 24 weeks
|
Drug: dalcetrapib
900mg po daily for 24 weeks
|
Placebo Comparator: Placebo
Placebo po daily for 24 weeks
|
Drug: Placebo
po daily for 24 weeks
|
- Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ]
- Change from baseline in total cholesterol (TC), triglycerides (TG), HDL-C, LDL-C, cholesterol ester transfer protein (CETP) mass and activity, apolipoproteins A1 (ApoA1), apolipoproteins B (ApoB) [ Time Frame: Weeks 24 ]
- Adverse events (AEs), laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353522
United States, Illinois | |
Chicago, Illinois, United States, 60610 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46260 | |
United States, Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Kentucky | |
Louisville, Kentucky, United States, 40213 | |
United States, Maryland | |
Bethesda, Maryland, United States, 20817 | |
United States, Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, North Carolina | |
Statesville, North Carolina, United States, 28677 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45212 | |
Cincinnati, Ohio, United States, 45219 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84132 | |
Germany | |
Berlin, Germany, 10707 | |
Bochum, Germany, 06097 | |
Dortmund, Germany, 44137 | |
Erlangen, Germany, 91054 | |
Freiburg, Germany, 79106 | |
Hamburg, Germany, 20249 | |
München, Germany, 80336 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00353522 History of Changes |
Other Study ID Numbers: |
NC19453 |
First Posted: | July 18, 2006 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Dalcetrapib Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |