Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8457 · 1 trial · 1 indication
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 ...
MK-8457 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is currently in Phase 1 clinical development and is not yet approved for any use.
MK-8457 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for hypertension.
MK-8457 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The only clinical trial for MK-8457, a Phase 1 study in hypertensive participants, has been completed.
MK-8457 has one completed clinical trial, identified as NCT01446003, titled "A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)." This Phase 1 study enrolled 31 participants with hypertension in the United States.
The clinical trial for MK-8457, NCT01446003, was a randomized, double-blind, controlled study. It enrolled 31 participants with hypertension and was conducted in the United States. The trial has been completed.