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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00652431 |
This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days
Condition | Intervention | Phase |
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Hypercholesterolemia Hyperlipidemia |
Drug: Vytorin + Niaspan Drug: Vytorin Drug: Niaspan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | SCH 465981: Assessment of Bi-Directional Interaction Between Components of Vytorin® (Ezetimibe and Simvastatin) and Niaspan® (Niacin Extended-Release Tablets) in Healthy Subjects |
Enrollment: | 18 |
Study Start Date: | May 2007 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vytorin + Niaspan: Experimental
NIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 + VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
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Drug: Vytorin + Niaspan
Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
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Vytorin: Active Comparator
VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
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Drug: Vytorin
Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days
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Niaspan: Active Comparator
NIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 for a total of 7 days of treatment
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Drug: Niaspan
Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The subject must meet ALL the criteria listed below for entry:
Vital sign measurements (taken after ~3 minutes in a seated position) must be within the following ranges:
Women of child-bearing potential must agree to use medically accepted methods of contraception prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Acceptable methods of contraception include:
Exclusion Criteria:
The subject will be excluded from entry if ANY of the criteria listed below are met:
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04955, Doc ID: 3498819 |
Study First Received: | March 31, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00652431 |
Health Authority: | United States: Food and Drug Administration |
Nicotinic Acids Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe Healthy |
Metabolic disorder Niacin Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antilipemic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Vitamins Micronutrients |