Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

Organon

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Drug: Vytorin (R) (Ezetimibe + Simvastatin)

Study type: Observational

Funder types: Industry

Identifiers

NCT00909389

P05647

Details and patient eligibility

About

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.

Enrollment: 4,748 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,748 participants in 1 patient group

Filipino Patients with Hypercholesterolemia

Treatment:

Drug: Vytorin (R) (Ezetimibe + Simvastatin)