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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00651963
First received: March 31, 2008
Last updated: March 9, 2017
Last verified: March 2017
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Study First Received: March 31, 2008
Last Updated: March 9, 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

ClinicalTrials.gov processed this record on April 26, 2017