Conditions: Essential Hypertension
Keywords: Essential hypertension High blood pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 266
Healthy volunteers: no

Brief summary:
This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Detailed description:

Arms:
arm 1: Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks. arm 2: Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.

Interventions: intervention 1: LCZ696 intervention 2: Amlodipine intervention 3: Placebo
Intervention descriptions: intervention 1: LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day. intervention 2: Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day. intervention 3: Matching placebo to LCZ696

Protocol document: