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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 31, 2008
Last updated: May 4, 2015
Last verified: May 2015
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 4

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:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Lipid profile [ Time Frame: Over 8 Weeks ] [ Designated as safety issue: No ]

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

    Ezetimibe 10 mg daily was added during 4 weeks.

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

    Other Names:
    • Zetia®
    • MK0653

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

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
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Please refer to this study by its identifier: NCT00651963

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651963     History of Changes
Other Study ID Numbers: 0653-141  MK0653-141  2008_007 
Study First Received: March 31, 2008
Last Updated: May 4, 2015
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on May 02, 2016