Conditions: Hypertension
Keywords: hypertension systolic blood pressure exercise test cardiovascular disease aliskiren valsartan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension.

Detailed description:

Arms:
arm 1: For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days). arm 2: For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).

Interventions: intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo to aliskiren intervention 4: Placebo to valsartan
Intervention descriptions: intervention 1: Aliskiren was supplied in 150 mg tablets. intervention 2: Valsartan was supplied in 160 mg capsules. intervention 3: Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg. intervention 4: Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Protocol document: