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MK0736

Phase 2

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Trials Updated: Jul 3, 2015

MK0736 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2006

MK0736 target and mechanism

Molecular targetHSD11B1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment249

FDA Designations

No designations recorded

MK0736 clinical trials

MK0736 · 1 trial · 1 indication

Phase 2 1
NCT00274716Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)Hypertension
COMPLETED249 Analytics
PHASE2COMPLETED
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Baseline and Week 12 (end of Phase A)

Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.

Number of Participants Who Reported a Clinical Adverse Event
24 weeks

An AE is 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

Number of Participants Who Reported a Laboratory Adverse Event
24 weeks

An AE is 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
24 weeks

An AE is 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
24 weeks

An AE is 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

Secondary Endpoints

Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Baseline and Week 12 (end of Phase A)
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Baseline and Week 12 (end of Phase A)
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Baseline and Week 12 (end of Phase A)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High BMI:MK-0736 2mg→PlaceboEXPERIMENTALParticipants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0736 7mg→PlaceboEXPERIMENTALParticipants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0916 6mg→MK-0916 6mgEXPERIMENTALParticipants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
High BMI:Placebo→PlaceboPLACEBO_COMPARATORParticipants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:MK-0916 6mg→MK-0916 6mgEXPERIMENTALParticipants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:Placebo→PlaceboPLACEBO_COMPARATORParticipants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Interventions

NameTypeDescription
MK0736DRUG -
MK0916DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Hypertension systolic blood pressure (SBP) \</= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg Exclusion Criteria: * Pre-menopausal women * patients currently taking more than two (2) blood pressure lowering medications * Body Mas Index (BMI)\>40 kg/m2 (morbidly ob...

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Frequently asked questions about MK0736

What is MK0736 used for?

MK0736 is an investigational small molecule being studied for the treatment of hypertension, or high blood pressure. It was evaluated in a Phase 2 clinical trial in patients with hypertension. MK0736 is not approved for any indication and remains in clinical development.

What does MK0736 target?

MK0736 targets HSD11B1, also known as 11 beta hydroxysteroid dehydrogenase type 1. It is an inhibitor of this enzyme. By inhibiting HSD11B1, MK0736 is designed to act on a pathway relevant to blood pressure regulation, which is the basis for its study in hypertension.

Who is developing MK0736?

MK0736 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the clinical trial of MK0736 in hypertension.

What phase is MK0736 in?

MK0736 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is MK0736 in?

MK0736 has been studied in one completed Phase 2 trial, NCT00274716, titled Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension. The trial enrolled 249 patients, was randomized, double blind, and placebo controlled, and included adults 18 years and older of all sexes.