Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

NCT ID: NCT00651963

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-03-31

Brief Summary

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Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.

Detailed Description

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Conditions

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Lipid Metabolism Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ezetimibe

Ezetimibe 10 mg daily was added during 4 weeks.

The patients continued taking their usual Statin without titrating the dose.

Intervention Type DRUG

Other Intervention Names

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Zetia® MK0653

Eligibility Criteria

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Inclusion Criteria

* \> 18 years old
* Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score

Exclusion Criteria

* Pregnancy, Breast Feeding
* Moderate/Sever Liver Disease: Child Score \> Or = To 7
* Fibrates Terminal Disease
* Contraindications To Receive ezetimibe
* Contraindications To Receive Statins
* Mental Disability
* Hypersensitivity To ezetimibe
* On another Clinical Research Trial
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

Other Identifiers

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MK0653-141

Identifier Type: -

Identifier Source: secondary_id

2008_007

Identifier Type: -

Identifier Source: secondary_id

0653-141

Identifier Type: -

Identifier Source: org_study_id

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