Conditions: Hypertension
Keywords: Essential hypertension Uncontrolled hypertension Antihypertensive agents Blood pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 327
Healthy volunteers: no

Brief summary:
This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).

Detailed description:

Arms:
arm 1: Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. arm 2: Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

Interventions: intervention 1: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E) intervention 2: Losartan potassium intervention 3: Amlodipine besylate intervention 4: Placebo to MK-0954E intervention 5: Placebo to losartan potassium intervention 6: Placebo to amlodipine besylate
Intervention descriptions: intervention 1: One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks. intervention 2: One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks. intervention 3: One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks. intervention 4: One tablet, containing placebo, orally, once daily, for 8 weeks. intervention 5: One tablet, containing placebo, orally, once daily, for 8 weeks. intervention 6: One capsule, containing placebo, orally, once daily, for 8 weeks.

Protocol document: