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NCT00651963 Clinical Trial

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

Lipid Metabolism Disorder Clinical Trial

Official title:
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651963
Other study ID # 0653-141
Secondary ID MK0653-1412008_0
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2004
Est. completion date March 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ezetimibe
Ezetimibe 10 mg daily was added during 4 weeks. The patients continued taking their usual Statin without titrating the dose.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Lipid profile Over 8 Weeks
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