Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

This study has been completed.

First Received on March 31, 2008. No Changes Posted

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00651963

Purpose

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.

Condition	Intervention	Phase
Lipid Metabolism Disorder	Drug: ezetimibe	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Disorders Statins

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Lipid profile [ Time Frame: Over 8 Weeks ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	September 2004
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Ezetimibe 10 mg daily was added during 4 weeks. The patients continued taking their usual Statin without titrating the dose.

Other Names:

Zetia®
MK0653

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651963

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00651963 History of Changes
Other Study ID Numbers:	2008_007, MK0653-141
Study First Received:	March 31, 2008
Last Updated:	March 31, 2008
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:

Metabolic Diseases
Lipid Metabolism Disorders
Dyslipidemias
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012