|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00653796 |
Purpose
This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Atherosclerosis |
Drug: Ezetimibe + Atorvastatin Drug: Atorvastatin |
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 Multicentre, Randomised, Parallel Group, Placebo-Controlled Study Comparing the Efficacy, Safety, And Tolerability of the Daily Co-Administration of Ezetimibe 10 mg With Atorvastatin 10 mg vs. Ezetimibe Placebo With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolaemia and Coronary Heart Disease |
| Enrollment: | 148 |
| 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 + Atorvastatin: Experimental |
Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
|
| Atorvastatin: Active Comparator |
Drug: Atorvastatin
oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
|
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: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P03434 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653796 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Vascular Diseases Enzyme Inhibitors Ezetimibe |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |