A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496730
• Other study ID #: 0653A-129
• Secondary ID: MK0653A-1292007_
• Status: Completed
• Phase: Phase 3
• Start date: July 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement

• No history of diabetes and 100 <=LDL-C <=250 mg/dl

Exclusion Criteria:

• Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months

• Congestive heart failure defined by New York Heart Association (NYHA) class III or IV

• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins

• Uncontrolled hypertension

• Unstable angina

Related Conditions & MeSH terms

• Hypercholesterolemia
• Metabolic Syndrome

Intervention

Drug:
• simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
• Comparator: atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.		Baseline and Week 8
Primary	Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.		Baseline and 8 Weeks
Secondary	Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.	Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.; LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).	Baseline and 8 weeks