Back to resultsOpen Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)
Primary Purpose
Lipid Metabolism Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Metabolism Disorder
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Lipid profile
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651963
Brief Title
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)
Official Title
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Other Intervention Name(s)
Zetia®, MK0653
Intervention Description
Ezetimibe 10 mg daily was added during 4 weeks.
The patients continued taking their usual Statin without titrating the dose.
Primary Outcome Measure Information:
Title
Lipid profile
Time Frame
Over 8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
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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