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)
May 8, 2024 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
256
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vytorin®
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
Other Names:
|
|
Active Comparator: atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
atorvastatin 10 mg; tablet, once daily, 8 Weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Time Frame: Baseline and 8 Weeks
|
Baseline and 8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Baseline and 8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.
Time Frame: Baseline and Week 8
|
Baseline and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
July 2, 2007
First Submitted That Met QC Criteria
July 2, 2007
First Posted (Estimated)
July 4, 2007
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Insulin Resistance
- Hyperinsulinism
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Metabolic Syndrome
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Simvastatin
- Ezetimibe
Other Study ID Numbers
- 0653A-129
- MK0653A-129
- 2007_017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.