drugset / Trial / NCT02460159

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)

NCT02460159

Phase 3 Completed 135 enrolled Organon and Co
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

Timeline

Start
2015-06-23
Primary completion
2016-12-22
Completion
2016-12-22

Publications

  • Results Teramoto T, Yokote K, Nishida C, Tershakovec A, Oshima N, Takase T, Hirano T. A Phase III open-label clinical trial to assess the long-term safety of ezetimibe and atorvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2017;33(8):655-670.

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg Oral
Subject Atorvastatin Small molecule 20 mg Oral
Subject Ezetimibe Unknown 10 mg Oral