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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | Oral |
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Ezetimibe | Unknown | 10 mg | Oral |