Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2414 participants
INTERVENTIONAL
2007-06-15
2008-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
Comparator: simvastatin
MK-0524A
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Placebo
MK-0524B
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
Comparator: simvastatin
MK-0524A
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Placebo
MK-0524B
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
Comparator: simvastatin
MK-0524A
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Placebo
MK-0524B
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
Comparator: simvastatin
MK-0524A
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Placebo
MK-0524B
Interventions
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Comparator: simvastatin
MK-0524A
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Placebo
MK-0524B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meets one of the following triglyceride (TG) criteria:
1. is on niacin, statin, or fibrate and has TG \<500 mg/dL at or within 6 months of washout
2. is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG \<600 mg/dL at or within 6 months of screening
Exclusion Criteria
* is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
* has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
* has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)
18 Years
85 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Study Documents
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Document Type: CSR Synopsis Link
View DocumentOther Identifiers
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MK-0524B-063
Identifier Type: OTHER
Identifier Source: secondary_id
2007_504
Identifier Type: -
Identifier Source: secondary_id
0524B-063
Identifier Type: -
Identifier Source: org_study_id
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