Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01446003 | A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1) | PHASE1 | COMPLETED | 31 | — | — | Oct 25, 2011 | Mar 3, 2012 | Feb 5, 2019 | 2 | United States |
SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.
An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| MK-8457-Placebo Sequence | EXPERIMENTAL | Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout. |
| Placebo-MK-8457 Sequence | EXPERIMENTAL | Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout. |
| Name | Type | Description |
|---|---|---|
| MK-8457 | DRUG | 10 x 10-mg capsule BID for 10 days |
| Placebo for MK-8457 | DRUG | 10 x 10-mg capsule BID for 10 days |
Inclusion Criteria: * If female, must be of non-childbearing potential * If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug * Body mass index (BMI) ≤35 kg/m\^2 ...