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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00652444 |
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: ezetimibe Drug: simvastatin Drug: Placebo (Unspecified) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
Enrollment: | 120 |
Study Start Date: | September 2003 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
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Drug: ezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
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2: Experimental
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
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Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Drug: Placebo (Unspecified)
Matching ezetimibe placebo
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Ages Eligible for Study: | 18 Years to 75 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: | 2008_004 |
Study First Received: | March 31, 2008 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00652444 |
Health Authority: | United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health |
Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe |
Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |