drugset / Trial / NCT02741245

A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)

NCT02741245

Phase 3 Completed 321 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.

Timeline

Start
2016-06-09
Primary completion
2017-01-18
Completion
2017-01-18

Publications

  • Results Teramoto T, Yokote K, Nishida C, Oshima N, Takase T. A phase III clinical trial to study the efficacy and safety of ezetimibe plus rosuvastatin combination therapy in Japanese patients with hypercholesterolemia - A randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(11):881-896.

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Subject Rosuvastatin Small molecule 2.5 mg
Subject Rosuvastatin Small molecule 5 mg

Indications