Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo to aliskiren; Drug: Valsartan; Drug: Aliskiren; Drug: Placebo to valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819767

CSPP100A2406

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg measured at rest
• Patients able to exercise and to reach 85% of their predicted heart rate during a standard exercise test on a treadmill according to the Bruce Protocol

Exclusion criteria

• Patients not confident in exercising or not able to exercise
• Absolute contraindication to exercise
• Mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg measured at rest

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Aliskiren

Experimental group

Description:

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).

Treatment:

Drug: Placebo to valsartan

Drug: Placebo to aliskiren

Drug: Aliskiren

Valsartan

Active Comparator group

Description:

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).

Treatment:

Drug: Placebo to valsartan

Drug: Placebo to aliskiren

Drug: Valsartan