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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01025843 | Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001) | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2009 | May 1, 2010 | Sep 21, 2018 | - | — |
An AE is 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.
An AE is 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.
| Arm | Type | Description |
|---|---|---|
| Pbo → 5 mg → Candesartan → 24 mg → 38 mg | EXPERIMENTAL | Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| 1 mg → 5 mg → 12 mg → Candesartan → Pbo | EXPERIMENTAL | 1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods. |
| 1 mg → Candesartan → Pbo → 24 mg → 38 mg | EXPERIMENTAL | 1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| 1 mg → 5 mg → 12 mg → Pbo → Candesartan | EXPERIMENTAL | 1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods. |
| Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan | EXPERIMENTAL | Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods. |
| 2 mg→Pbo → Candesartan → Pbo fed→38 mg | EXPERIMENTAL | 2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| 2 mg→Candesartan→Pbo→Candesartan fed→38 mg | EXPERIMENTAL | 2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| 2 mg → 8 mg → 18 mg → 2 mg fed → Pbo | EXPERIMENTAL | 2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods. |
| Candesartan→8 mg→ 18 mg →2 mg fed→38 mg | EXPERIMENTAL | Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| Candesartan→Pbo → 12 mg → 24 mg→38 mg | EXPERIMENTAL | Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. |
| Name | Type | Description |
|---|---|---|
| MK-5478 | DRUG | In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg. |
| Comparator: Candesartan cilexetil | DRUG | Single dose administration of candesartan, 32 mg oral tablet |
| Comparator: Pbo | DRUG | Placebo |
Inclusion Criteria: Part I: * Is a male between 18 to 50 years of age * Is in good health * Is a non-smoker Part II: * Is male of non-child bearing potential between 18 and 50 years of age * Has hypertension (high blood pressure) Exclusion Criteria: Part I and Part II: * Has a history of stro...