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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01307033 | A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351) | PHASE3 | COMPLETED | 278 | — | — | Mar 29, 2011 | Dec 4, 2012 | May 17, 2024 | - | — |
| NCT01307046 | MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352) | PHASE3 | COMPLETED | 336 | — | — | Mar 29, 2011 | Feb 7, 2012 | May 17, 2024 | - | — |
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).
| Arm | Type | Description |
|---|---|---|
| MK-954H (L50/H12.5) | ACTIVE_COMPARATOR | One 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) | EXPERIMENTAL | One 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-0954A | EXPERIMENTAL | Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. |
| Losartan | ACTIVE_COMPARATOR | Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks. |
| Name | Type | Description |
|---|---|---|
| MK-0954A | DRUG | Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily |
| MK-954H | DRUG | Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily |
| Placebo to MK-0954A | DRUG | Placebo tablet to match MK-0954A, once daily |
| Placebo to MK-954H | DRUG | Placebo tablet to match MK-954H, once daily |
| Losartan | DRUG | Tablet containing losartan potassium (100 mg), once daily |
| Placebo to losartan 100 mg | DRUG | Placebo tablet to match losartan 100 mg, once daily |
| Placebo to losartan 50 mg | DRUG | Placebo tablet to match losartan 50 mg, once daily |
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 \< ...