- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400439
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
December 16, 2019 updated by: Hoffmann-La Roche
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453.
Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po).
The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
-
Indianapolis, Indiana, United States, 46260
-
-
Iowa
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Iowa City, Iowa, United States, 52242
-
-
Kentucky
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Louisville, Kentucky, United States, 40213
-
-
Maryland
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Bethesda, Maryland, United States, 20817
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-
Minnesota
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Minneapolis, Minnesota, United States, 55455
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North Carolina
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Statesville, North Carolina, United States, 28677
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Ohio
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Cincinnati, Ohio, United States, 45212
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Cincinnati, Ohio, United States, 45219
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Utah
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Salt Lake City, Utah, United States, 84132
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who have completed treatment on study NC19453.
Exclusion Criteria:
- any significant lymph node abnormalities at the end of study NC19453.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
po daily for 24 weeks
|
Experimental: dalcetrapib (RO4607381)
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900mg po daily for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change From Baseline in HDL-C
Time Frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
|
Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Time Frame: Baseline and Week 24 (Week 48 from start of NC19453)
|
Baseline and Week 24 (Week 48 from start of NC19453)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
November 15, 2006
First Submitted That Met QC Criteria
November 15, 2006
First Posted (Estimate)
November 16, 2006
Study Record Updates
Last Update Posted (Actual)
January 3, 2020
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Dalcetrapib
Other Study ID Numbers
- NC20716
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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