Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00271817 |
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: Comparator: ezetimibe/simvastatin + niacin (ER) Drug: Comparator: Placebo to ezetimibe/simvastatin Drug: Comparator: niacin (ER) tablet Drug: Comparator: ezetimibe (+) simvastatin Drug: Comparator: Placebo to Niacin (ER) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicent, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia |
Enrollment: | 1220 |
Study Start Date: | December 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
ezetimibe/simvastatin combination tablet + niacin (ER)
|
Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks
|
2: Active Comparator
ezetimibe/simvastatin
|
Drug: Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~16 weeks.
Drug: Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~16 weeks.
|
3: Active Comparator
Niacin (ER)
|
Drug: Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~16 weeks.
Drug: Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~16 weeks
|
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_091, MK0653A-091 |
Study First Received: | January 3, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00271817 |
Health Authority: | United States: Food and Drug Administration |
Nicotinic Acids Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe |
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 |