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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353522
First received: July 17, 2006
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 2 arm study will investigate the efficacy and safety of RO4607381 in patien ts with coronary heart disease, or CHD risk equivalent. After a pre-randomizatio n 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 10-80m g daily, and changes in cholesterol level and lipoprotein metabolism will be mea sured. The anticipated time on study treatment is 3-12 months, and the target sa mple 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:


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: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014