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drugset / Trial / NCT00157911

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

NCT00157911 ↗

Phase 3 Completed 136 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2002-12
Primary completion
2003-10
Completion
2003-12

Publications

  • Results Bae JW, Kim HS, Lee SC, Han KH, Jeon ES. The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia. Korean J Med. 2005;68(5):487-497 [in Korean].

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown — —
Subject Simvastatin Small molecule — —

Indications

hyperlipidemia