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MK-0954A

Phase 3

Hypertension | Small molecule | Cardiovascular |Organon & Co.|Last Updated: May 17, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment614

FDA Designations

No designations recorded

Clinical trial landscape

MK-0954A · 2 trials · 1 indication

Phase 3 2
NCT01307033A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)Hypertension
COMPLETED278 Analytics
NCT01307046MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)Hypertension
COMPLETED336 Analytics
PHASE3COMPLETED
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
HypertensionUnlock trial analytics
PHASE3COMPLETED
MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)
Up to 52 weeks
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
Baseline and Week 8

Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

Percentage of Participants Who Experienced at Least One Adverse Event (AE)
8 weeks

Secondary Endpoints

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Baseline and Week 8 (End of Double-blind Period)
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Baseline and Week 8 (End of Double-blind Period)
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
Baseline and Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-954H (L50/H12.5)ACTIVE_COMPARATOROne combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
MK-0954A (L100/H12.5)EXPERIMENTALOne combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
MK-0954AEXPERIMENTALParticipants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
LosartanACTIVE_COMPARATORParticipants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

Interventions

NameTypeDescription
MK-0954ADRUGTablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
MK-954HDRUGTablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
Placebo to MK-0954ADRUGPlacebo tablet to match MK-0954A, once daily
Placebo to MK-954HDRUGPlacebo tablet to match MK-954H, once daily
LosartanDRUGTablet containing losartan potassium (100 mg), once daily
Placebo to losartan 100 mgDRUGPlacebo tablet to match losartan 100 mg, once daily
Placebo to losartan 50 mgDRUGPlacebo tablet to match losartan 50 mg, once daily
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Eligibility Criteria

Age Range20 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Participant has a diagnosis of essential hypertension. * Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication. * Participant has a mean trough SiDBP of \>=90mmHg and \< ...

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Frequently asked questions about MK-0954A

What is MK-0954A used for?

MK-0954A is an investigational small molecule being developed for the treatment of hypertension, also known as high blood pressure. It is currently in Phase 3 clinical development and has been studied in patients with essential hypertension.

Who makes MK-0954A?

MK-0954A is being developed by Organon & Co. (NYSE: OGN). The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with hypertension.

What phase is MK-0954A in?

MK-0954A is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, but the drug remains under investigation for hypertension.

What clinical trials is MK-0954A in?

MK-0954A has been studied in two completed Phase 3 trials: NCT01307033, a long-term safety study in patients with essential hypertension, and NCT01307046, a study in Japanese patients with essential hypertension not adequately controlled with losartan. Both trials were randomized, double-blind, and active-controlled.

Is MK-0954A the same as losartan?

No, MK-0954A is not the same as losartan. In one clinical trial (NCT01307046), MK-0954A was studied in Japanese patients whose hypertension was not adequately controlled with losartan, indicating that losartan is a separate medication used as a comparator or prior treatment.