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

Purpose

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	Intervention	Phase
Coronary Heart Disease	Drug: Placebo Drug: dalcetrapib	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in TC, TG, HDL-C, LDL-C, CETP mass and activity, ApoAl, ApoB [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, change in mesenteric lymph nodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]


Enrollment:	135
Study Start Date:	July 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: dalcetrapib 900mg po daily for 24 weeks
Placebo Comparator: 2	Drug: Placebo po daily for 24 weeks

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353522

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

No publications provided


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353522 History of Changes
Other Study ID Numbers:	NC19453
Study First Received:	July 17, 2006
Last Updated:	February 23, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia	Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 25, 2015