Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lipid Metabolism Disorder
Intervention: ezetimibe (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Lipid profile
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2004
Last updated: March 31, 2008
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