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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren

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).

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren was supplied in 150 mg tablets.

Placebo to aliskiren

Intervention Type DRUG

Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.

Placebo to valsartan

Intervention Type DRUG

Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Valsartan

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).

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

Valsartan was supplied in 160 mg capsules.

Placebo to aliskiren

Intervention Type DRUG

Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.

Placebo to valsartan

Intervention Type DRUG

Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Interventions

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Aliskiren

Aliskiren was supplied in 150 mg tablets.

Intervention Type DRUG

Valsartan

Valsartan was supplied in 160 mg capsules.

Intervention Type DRUG

Placebo to aliskiren

Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.

Intervention Type DRUG

Placebo to valsartan

Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No