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An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

NCT ID: NCT00092664

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-09-30

Brief Summary

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The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* High cholesterol

Exclusion Criteria

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73. doi: 10.1016/j.clinthera.2004.11.016.

Reference Type BACKGROUND
PMID: 15639688 (View on PubMed)

Feldman T, Ose L, Shah A, Zakson M, Meehan A, Johnson-Levonas AO, Maccubbin D, Tribble DL, Veltri E, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin versus simvastatin monotherapy in hypercholesterolemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Spring;5(1):13-21. doi: 10.1089/met.2006.0033.

Reference Type BACKGROUND
PMID: 18370810 (View on PubMed)

Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.

Reference Type BACKGROUND
PMID: 17560879 (View on PubMed)

Ose L, Reyes R, Johnson-Levonas AO, Sapre A, Tribble DL, Musliner T. Effects of ezetimibe/simvastatin on lipoprotein subfractions in patients with primary hypercholesterolemia: an exploratory analysis of archived samples using two commercially available techniques. Clin Ther. 2007 Nov;29(11):2419-32. doi: 10.1016/j.clinthera.2007.10.004.

Reference Type BACKGROUND
PMID: 18158082 (View on PubMed)

Other Identifiers

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2004_043

Identifier Type: -

Identifier Source: secondary_id

0653A-038 Extension

Identifier Type: -

Identifier Source: org_study_id

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