Status:
COMPLETED
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
Eligibility Criteria
Inclusion
- Outpatient men or women, age 18 years and above
- Patients with primary (heterozygous familial and non-familial) hypercholesterolemia
Exclusion
- Known hypersensitivity to Ezetimibe and Simvastatin
- Moderate to severe hepatic insufficiency
- Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal
- Pregnancy or lactation
- Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
4748 Patients enrolled
Trial Details
Trial ID
NCT00909389
Start Date
November 1 2006
End Date
November 1 2008
Last Update
February 9 2022
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