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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00274716 | Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED) | PHASE2 | COMPLETED | 249 | — | — | Nov 1, 2005 | Jan 1, 2007 | Jul 3, 2015 | - | — |
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| High BMI:MK-0736 2mg→Placebo | EXPERIMENTAL | Participants 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→Placebo | EXPERIMENTAL | Participants 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 6mg | EXPERIMENTAL | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| High BMI:Placebo→Placebo | PLACEBO_COMPARATOR | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| Low BMI:MK-0916 6mg→MK-0916 6mg | EXPERIMENTAL | Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| Low BMI:Placebo→Placebo | PLACEBO_COMPARATOR | Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) |
| Name | Type | Description |
|---|---|---|
| MK0736 | DRUG | - |
| MK0916 | DRUG | - |
| Placebo | DRUG | - |
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...