Conditions: Hypertension
Keywords: Essential hypertension Antihypertensive agents Blood pressure Uncontrolled hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 286
Healthy volunteers: no

Brief summary:
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg \[L50\] (+) hydrochlorothiazide 12.5 mg \[H12.5\] (+) amlodipine besylate 5mg \[A5\]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in Japanese participants. In the second part, the safety and tolerability of long-term use of open-label MK-0954E in participants with hypertension will be evaluated. The primary hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese participants with essential hypertension who are not adequately controlled following a 8-week treatment with filter period study drug of MK-954H.

Detailed description:

Arms:
arm 1: One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open label extension. arm 2: One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension

Interventions: intervention 1: L50/H12.5/A5 intervention 2: L50/H12.5 intervention 3: Placebo to L50/H12.5/A5 intervention 4: Placebo to L50/H12.5
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: