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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00651274 |
Purpose
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis Hypercholesterolemia Coronary Heart Disease |
Drug: Ezetimibe Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-Administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Simvastatin 20 Mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease |
| Enrollment: | 144 |
| Study Start Date: | April 2003 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ezetimibe
N/A
|
Drug: Ezetimibe
oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
Other Name: SCH 58235
|
|
Placebo Comparator: Placebo
N/A
|
Drug: Placebo
oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00651274 History of Changes |
| Other Study ID Numbers: | P03476 |
| Study First Received: | March 31, 2008 |
| Last Updated: | April 1, 2008 |
| Health Authority: | United Arab Emirates: MOH |
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypercholesterolemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Simvastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |