Trials / Completed
CompletedNCT02741245
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
A Phase III, Randomized, Active Comparator-controlled, Clinical Trial to Study the Efficacy and Safety of MK-0653H in Japanese Patients With Hypercholesterolemia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 321 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ezetimibe 10 mg | |
| DRUG | Rosuvastatin 2.5 mg | |
| DRUG | Placebo for Ezetimibe | |
| DRUG | Placebo for Rosuvastatin |
Timeline
- Start date
- 2016-06-09
- Primary completion
- 2017-01-18
- Completion
- 2017-01-18
- First posted
- 2016-04-18
- Last updated
- 2024-05-16
- Results posted
- 2018-03-09
Source: ClinicalTrials.gov record NCT02741245. Inclusion in this directory is not an endorsement.