Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

NCT00409773 | Completed Phase 3 Results

• 2 other identifiers: 0653A-1072006_527
• Study Type: interventional
• Target: 1,143
• Locations: 0 countries
• Sites: N/A

Brief Summary

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

Conditions

Hypercholesterolemia; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6

  Baseline and 6 Weeks

Secondary Outcomes (14)

• Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6

  Baseline and 6 Weeks

• Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6

  Baseline and 6 Weeks

• Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6

  Baseline and 6 Weeks

• Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6

  Baseline and 6 Weeks

• Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6

  Baseline and 6 Weeks

Study Arms (5)

1

OTHER

Arm 1: drug + comparator + Placebo

Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

2

OTHER

Arm 2: drug + comparator + Placebo

Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

3

OTHER

Arm 3: drug + comparator + Placebo

Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

4

OTHER

Arm 4: drug + comparator + Placebo

Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

5

OTHER

Arm 5: drug + comparator + Placebo

Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

Interventions

ezetimibe (+) simvastatin DRUG

Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.

Also known as: MK0653A, Vytorin®

1; 2; 3; 4; 5

Comparator: atorvastatin calcium DRUG

Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Also known as: Lipitor ®

1; 2; 3; 4; 5

Comparator: Placebo (unspecified) DRUG

Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

1; 2; 3; 4; 5

Eligibility Criteria

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

You may qualify if:

• Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

You may not qualify if:

• A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
• Patient is likely to be greater than 20% noncompliant in taking study medications
• Patients with chronic medical conditions
• Patients with unstable doses of medications
• Pregnant or lactating women, women intending to become pregnant
• Patient is currently receiving prescription therapy with statins or other lipid-altering medications
• Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.

  PMID: 26336957 DERIVED

• Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.

  PMID: 22108151 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Metabolic Syndrome

Interventions

Ezetimibe, Simvastatin Drug Combination; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

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

Limitations and Caveats

15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 16, 2024
• Results First Posted: August 4, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share