Conditions: Hypertension Ankle Edema
Keywords: Pedal edema hypertension aliskiren amlodipine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Detailed description:

Arms:
arm 1: During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. arm 2: During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.

Interventions: intervention 1: Aliskiren/amlodipine intervention 2: Amlodipine intervention 3: Placebo to Aliskiren/amlodipine intervention 4: Placebo to Amlodipine
Intervention descriptions: intervention 1: Aliskiren/amlodipine 150/5 mg/day intervention 2: Amlodipine 5 mg/day. intervention 3: Placebo to Aliskiren/amlodipine 150/10 mg/day intervention 4: Placebo to Amlodipine 5 mg/day

Protocol document: