Conditions: Hypertension
Keywords: Hypertension Uncontrolled hypertension High blood pressure Uncontrolled high blood pressure Untreated high blood pressure Untreated hypertension Essential hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 334
Healthy volunteers: no

Brief summary:
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Detailed description:

Arms:
arm 1: One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. arm 2: 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Interventions: intervention 1: Losartan (+) amlodipine intervention 2: Placebo to match losartan/amlodipine tablets intervention 3: Amlodipine camsylate intervention 4: Placebo to match amlodipine
Intervention descriptions: intervention 1: One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. intervention 2: One tablet containing placebo, orally, once daily, for 8 weeks. intervention 3: 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. intervention 4: 2 tablets containing placebo, orally, once daily, for 8 weeks.

Protocol document: