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Sponsors and Collaborators: |
Schering-Plough Merck |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00653835 |
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolaemia Atherosclerosis |
Drug: Ezetimibe + Simvastatin Drug: Simvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SCH 58235: A Multicenter, Randomised, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, and Tolerability Of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg vs Ezetimibe Placebo With Simvastatin 20 mg in Untreated Subjects With Primary Hypercholesterolaemia And Coronary Heart Disease (Protocol P03435) |
Enrollment: | 153 |
Study Start Date: | September 2003 |
Study Completion Date: | August 2004 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Ezetimibe + Simvastatin: Experimental |
Drug: Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
|
Simvastatin: Active Comparator |
Drug: Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03435 |
Study First Received: | April 1, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00653835 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Simvastatin Vascular Diseases Ezetimibe |
Arteriosclerosis Coronary Disease Metabolic disorder Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |