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MK-7145

Phase 1

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Sep 21, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

MK-7145 · 1 trial · 1 indication

Phase 1 1
NCT01370655A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)Hypertension
COMPLETED46 Analytics
PHASE1COMPLETED
A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)
Baseline and Day 28

Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)
Baseline and Day 28

Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.

Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1
Baseline (Day-1) and Day 1

Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.

Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.

Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)
up to 4 weeks of each treatment period

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.

Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)
Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.

Secondary Endpoints

Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28
Baseline (Day -1) and Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-7145 6 mg (Treatment A)EXPERIMENTALMK-7145 3 mg (three x 1-mg MK-7145 capsules administered orally) and placebo to HCTZ (two 12.5-mg capsules) then three x 1-mg MK-7145 capsules 4 hours later, daily for 4 weeks.
MK-7145 3 mg (Treatment B)EXPERIMENTALMK-7145 3 mg (one 2mg MK-7145 and one MK-7145 placebo capsule) then one 1-mg MK-7145 capsule and two MK-7145 placebo capsules 4 hours later and placebo to HCTZ (2 capsules once daily) daily for 4 weeks.
Hydrochlorothiazide 25 mg (Treatment C)ACTIVE_COMPARATORHCTZ 25 mg (two 12.5-mg capsules) and placebo to MK-7145 (one 3-mg capsule) then placebo for MK-7145 (one 3-mg capsule) 4 hours later daily for 4 weeks.
Placebo (Treatment D)PLACEBO_COMPARATORPlacebo to MK-7145 (2 x 3-mg capsules) and placebo to HCTZ 25 mg (2 capsules) then placebo to MK-7145 (2 x 3-mg capsules) 4 hours later daily for 4 weeks

Interventions

NameTypeDescription
MK-7145DRUG -
Hydrochlorothiazide (HCTZ)DRUG -
Placebo to MK-7145DRUG -
Placebo to HCTZDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexMALE
Healthy VolunteersNo

Inclusion criteria: * Diagnosis of essential hypertension * Body mass index (BMI) ≤35 kg/m\^2 * Participant in general good health * No history of clinically significant arrhythmias or clinically significant abnormality on electrocardiogram (ECG) * No history of clinically significant cardiac disea...

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Frequently asked questions about MK-7145

What is MK-7145 used for?

MK-7145 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 has not been approved by regulatory authorities.

What does MK-7145 target?

The specific molecular target of MK-7145 has not been disclosed in available information. It is being studied for its potential to lower blood pressure in patients with hypertension, but its mechanism of action has not been publicly detailed.

Who makes MK-7145?

MK-7145 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.

What phase is MK-7145 in?

MK-7145 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 clinical trial for the drug has been completed, but it remains in early-stage development.

What clinical trials is MK-7145 in?

MK-7145 has one completed Phase 1 clinical trial, identified as NCT01370655. This randomized, double-blind, placebo-controlled study evaluated MK-7145 compared to placebo and hydrochlorothiazide for lowering blood pressure in male participants with hypertension. The trial enrolled 46 participants.

Is MK-7145 the same as hydrochlorothiazide?

No, MK-7145 is not the same as hydrochlorothiazide. Hydrochlorothiazide is a diuretic used as an active comparator in the clinical trial of MK-7145, which is an investigational drug being studied for hypertension. They are distinct compounds with different mechanisms of action.