Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: simvastatin (+) ezetimibe

• Registration Number: NCT00442897
• Lead Sponsor: Organon and Co

Brief Summary

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-01
• Results First Submitted QC: 2009-10-01
• Results First Posted: 2009-11-09
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

• Patients who are naïve to lowering lipid agent
• Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion Criteria

• Impaired kidney function
• Increased liver enzyme levels
• Pregnant women
• Hypersensitivity to ezetimibe and other statin agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	simvastatin (+) ezetimibe	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment	After 6 weeks of treatment	Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment	After 12 weeks of the treatment	If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.