NCT00462748

A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 786 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C \> 2mmol/l, who are able to attain the recommended LDL-C target of \< 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe (+) simvastatin	ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
DRUG	Comparator: atorvastatin	atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
DRUG	Comparator: rosuvastatin	rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-04-19
• Last updated: 2024-05-16
• Results posted: 2009-08-17