drugset / Trial / NCT01446003
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
RandomizedCrossoverTriple-blindTreatment
Summary
This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.
Timeline
- Start
- 2011-10-25
- Primary completion
- 2012-02-18
- Completion
- 2012-03-03
Outcome
Missed primary endpoint
registry Mean Difference (Final Values) 2.02 (90% CI -0.52 to 4.56) NCT01446003 ↗
registry LEAST_SQUARES_MEAN MK-8457 100 mg BID: -0.47 (-2.60 to 1.66) mmHg NCT01446003 ↗
registry LEAST_SQUARES_MEAN Placebo: -2.49 (-4.66 to -0.31) mmHg NCT01446003 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-8457 | Small molecule | 100 mg | — |