drugset / Trial / NCT02748057

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

NCT02748057

Phase 3 Completed 135 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.

Timeline

Start
2016-05-18
Primary completion
2017-12-11
Completion
2017-12-11

Publications

  • Results Teramoto T, Yokote K, Nishida C, Oshima N, Takase T. A Phase III Open-label clinical trial to assess the long-term safety of ezetimibe and rosuvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2018;34(11):765-82. (in Japanese) https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2018&vo=34&issue=11

Drugs

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