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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Drug: Placebo; Drug: dalcetrapib	Phase 2

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ]

Secondary Outcome Measures :

1. 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 ]
2. Adverse events (AEs), laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353522 History of Changes
Other Study ID Numbers:	NC19453
First Posted:	July 18, 2006
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