- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00664287
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
April 8, 2015 updated by: Merck Sharp & Dohme LLC
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 years of age or older and on a stable dose of lipid therapy
Exclusion Criteria:
- Patients lipid level is outside the recommended range
- Patients that are HIV positive
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 |
---|---|
Experimental: Group 1
Patients will remain on existing lipid-modifying therapy throughout the study.
Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily.
After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
|
Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily.
After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
Other Names:
|
Placebo Comparator: Group 2
Patients will remain on existing lipid-modifying therapy throughout the study.
Group 2: Patients will receive 1 placebo tablet daily.
After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.
|
Group 2: Patients will receive 1 placebo tablet daily.
After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.
Time Frame: 3 months
|
3 months
|
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
September 1, 2008
Primary Completion (Anticipated)
November 1, 2009
Study Registration Dates
First Submitted
April 21, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimate)
April 22, 2008
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0524A-082
- 2008_504
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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