Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
NCT00653835 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2024-08-15
Summary
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.
Conditions
- Hypercholesterolaemia
- Atherosclerosis
Interventions
- DRUG
-
Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
- DRUG
-
Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-09-01
- Primary Completion
- 2004-08-01
- Completion
- 2004-08-01
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