Eze/Simva Switch Study in Diabetics (0653A-807)

NCT ID: NCT00541697

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

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-19

Study Completion Date

2005-10-14

Brief Summary

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A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

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 / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Currently being treated with Atorvastatin 10 mg for at least 6 weeks
* Have Type 2 Diabetes
* Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria

* Consume more than 14 alcoholic drinks per week.
* Pregnant or lactating
* Have taken another investigation drug within 3 months of starting this study
* History of congestive heart failure, heart attack, coronary artery bypass surgery
* Uncontrolled high blood pressure
* HIV positive
* History of cancer in the last 5 years
Minimum Eligible Age

18 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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Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.

Reference Type BACKGROUND
PMID: 17451425 (View on PubMed)

Other Identifiers

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MK0653A-807

Identifier Type: -

Identifier Source: secondary_id

2007_645

Identifier Type: -

Identifier Source: secondary_id

0653A-807

Identifier Type: -

Identifier Source: org_study_id

NCT00093106

Identifier Type: -

Identifier Source: nct_alias

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