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)

NCT00496730 | Completed Phase 3 Results

• 3 other identifiers: 0653A-129MK0653A-1292007_017
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypercholesterolemia

Keywords

Metabolic Disorder

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 8 Weeks

Secondary Outcomes (1)

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

  Baseline and 8 weeks

Other Outcomes (1)

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

  Baseline and Week 8

Study Arms (2)

Vytorin®

EXPERIMENTAL

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

Drug: simvastatin (+) ezetimibe

atorvastatin

ACTIVE COMPARATOR

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Drug: Comparator: atorvastatin

Interventions

simvastatin (+) ezetimibe DRUG

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

Also known as: MK0653A, Vytorin®

Vytorin®

Comparator: atorvastatin DRUG

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Also known as: Lipitor®

atorvastatin

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypercholesterolemia; Metabolic Diseases

Interventions

Ezetimibe, Simvastatin Drug Combination; Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Simvastatin; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 16, 2024
• Results First Posted: November 17, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share