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

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ClinicalTrials.gov Identifier: NCT00651963
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Lipid Metabolism Disorder Drug: ezetimibe Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Lipid profile [ Time Frame: Over 8 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651963


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

Study Data/Documents: CSR Synopsis Link  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00651963     History of Changes
Other Study ID Numbers: 0653-141
MK0653-141
2008_007
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Dyslipidemias
Metabolic Diseases
Lipid Metabolism Disorders
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents