A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
This study has been completed.
Sponsor:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353522
First Posted: July 18, 2006
Last Update Posted: November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 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 |
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 ]
Secondary Outcome Measures:
- 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 ]
| 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: 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
|
Eligibility
Information from the National Library of Medicine
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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
Information from the National Library of Medicine
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
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
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00353522 History of Changes |
| Other Study ID Numbers: |
NC19453 |
| First Submitted: | July 17, 2006 |
| 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 |