A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

NCT ID: NCT00110435

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

1229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653A, ezetimibe (+) simvastatin

Intervention Type DRUG

Duration of Treatment: 4 wk placebo run in then 6 wk active

Intervention Type DRUG

Comparator: atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria

* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus that is poorly controlled
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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Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. doi: 10.4065/81.12.1579.

Reference Type BACKGROUND
PMID: 17165637 (View on PubMed)

Tomassini JE, Mazzone T, Goldberg RB, Guyton JR, Weinstock RS, Polis A, Jensen E, Tershakovec AM. Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia. Diabetes Obes Metab. 2009 Sep;11(9):855-64. doi: 10.1111/j.1463-1326.2009.01061.x. Epub 2009 Jun 5.

Reference Type BACKGROUND
PMID: 19508464 (View on PubMed)

Other Identifiers

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MK0653A-077

Identifier Type: -

Identifier Source: secondary_id

2005_022

Identifier Type: -

Identifier Source: secondary_id

0653A-077

Identifier Type: -

Identifier Source: org_study_id

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