A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholerolemia

Treatments: Drug: MK0653; ezetimibe / Duration of Treatment: 12 weeks; Drug: Comparator: simvastatin / Duration of Treatment: 12 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157911

0653-042

2005_065

MK0653-042

Details and patient eligibility

About

Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Korean males or females at least 18 years of age with hypercholesterolemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind