Skip to main content
OpenTrials
Completed

NCT Number: NCT00496730

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin (+) ezetimibe

Drug

simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks

Other names: MK0653A, Vytorin®

Comparator: atorvastatin

Drug

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Other names: Lipitor®

Primary outcomes

  1. Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.

    Time frame: Baseline and 8 Weeks

Secondary outcomes

  1. Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.

    Time frame: Baseline and 8 weeks

    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).

Other outcomes

  1. Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.

    Time frame: Baseline and Week 8

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2007
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.