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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01337674 | Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010) | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2011 | Nov 1, 2011 | Dec 24, 2018 | - | — |
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.
Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.
Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.
| Arm | Type | Description |
|---|---|---|
| Panel A: MK-4618 + Met → PBO + Met | EXPERIMENTAL | Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel A: PBO + Met → MK-4618 + Met | EXPERIMENTAL | Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel B: MK-4618 + Amlo → PBO + Amlo | EXPERIMENTAL | Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1. |
| Panel B: PBO + Amlo → MK-4618 + Amlo | EXPERIMENTAL | Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1. |
| Name | Type | Description |
|---|---|---|
| MK-4618 | DRUG | Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 |
| Placebo for MK-4618 | DRUG | Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 |
| Metoprolol | DRUG | Previously prescribed daily dose of open-label metoprolol for the duration of the study |
| Amlodipine | DRUG | Previously prescribed daily dose of open-label amlodipine for the duration of the study |
Inclusion Criteria: * Male or female not of childbearing potential * Not a nursing mother * Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only) for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take the designated daily dose of metopro...