Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)
NCT00651378 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2024-08-15
Summary
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of \<2.5 mmol/L. Treatment phase is 6 weeks.
Conditions
Interventions
- DRUG
-
Rosuvastatin
oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
- DRUG
-
Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
- DRUG
-
Double Atorvastatin
oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
Sponsors & Collaborators
- collaborator INDUSTRY
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-01
- Primary Completion
- 2005-06-01
- Completion
- 2005-06-01
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