A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
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
Outcome
Met primary endpoint
registry analysis (other test); Ezetimibe 10 mg vs Ezetimibe 10 mg+ Rosuvastatin 2.5 mg; p <0.001; Difference in M-estimates -35.9 (95% CI -39.9 to -32.0) NCT02741245 ↗
registry analysis (other test); Ezetimibe 10 mg vs Ezetimibe 10 mg+ Rosuvastatin 5.0 mg; p <0.001; Difference in M-estimates -41.8 (95% CI -45.8 to -37.9) NCT02741245 ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Subject | Rosuvastatin | Small molecule | 2.5 mg | — |
| Subject | Rosuvastatin | Small molecule | 5 mg | — |