Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
- Registration Number
- NCT00909389
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4748
Inclusion Criteria
- Outpatient men or women, age 18 years and above
- Patients with primary (heterozygous familial and non-familial) hypercholesterolemia
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Filipino Patients with Hypercholesterolemia Vytorin (R) (Ezetimibe + Simvastatin) -
- Primary Outcome Measures
Name Time Method Number of Participants Who Had an Adverse Event (AE). Throughout study up to Day 29 (Final Visit) The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.
All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
- Secondary Outcome Measures
Name Time Method