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

NCT ID: NCT00409773

Last Updated: 2024-05-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arm 1: drug + comparator + Placebo

Group Type OTHER

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Comparator: atorvastatin calcium

Intervention Type 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.

Comparator: Placebo (unspecified)

Intervention Type 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.

2

Arm 2: drug + comparator + Placebo

Group Type OTHER

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Comparator: atorvastatin calcium

Intervention Type 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.

Comparator: Placebo (unspecified)

Intervention Type 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.

3

Arm 3: drug + comparator + Placebo

Group Type OTHER

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Comparator: atorvastatin calcium

Intervention Type 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.

Comparator: Placebo (unspecified)

Intervention Type 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.

4

Arm 4: drug + comparator + Placebo

Group Type OTHER

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Comparator: atorvastatin calcium

Intervention Type 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.

Comparator: Placebo (unspecified)

Intervention Type 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.

5

Arm 5: drug + comparator + Placebo

Group Type OTHER

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Comparator: atorvastatin calcium

Intervention Type 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.

Comparator: Placebo (unspecified)

Intervention Type 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.

Interventions

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ezetimibe (+) simvastatin

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

Intervention Type DRUG

Comparator: atorvastatin calcium

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.

Intervention Type DRUG

Comparator: Placebo (unspecified)

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.

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin® Lipitor ®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type DERIVED
PMID: 26336957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22108151 (View on PubMed)

Other Identifiers

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2006_527

Identifier Type: -

Identifier Source: secondary_id

0653A-107

Identifier Type: -

Identifier Source: org_study_id

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