Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
NCT ID: NCT00804843
Last Updated: 2015-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2009-04-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Statin 80 mg + Niacin extended-release (ER)
Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
Atorvastatin/niacin extended-release
80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Simvastatin
(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Statin 10 mg
Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
Atorvastatin
10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Simvastatin
(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Interventions
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Atorvastatin/niacin extended-release
80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Atorvastatin
10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Simvastatin
(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Simvastatin
(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study
Exclusion Criteria
* Patient has recent history of acute coronary syndrome
* Patient has has coronary artery bypass graft surgery within 30 days of study start
* Patient has thyroid disease that has not been treated for more than 6 weeks
* Patient has donated blood within 8 weeks of study start
* Patient has poorly controlled diabetes mellitis
* Patient has human immunodeficiency virus (HIV) or Hepatitis B or C
* Patient is taking warfarin or other anticoagulants
* Patient is taking hormone replacement therapy
18 Years
90 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
Other Identifiers
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2008_598
Identifier Type: OTHER
Identifier Source: secondary_id
0000-111
Identifier Type: -
Identifier Source: org_study_id
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