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

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Valsartan (Drug); Placebo to aliskiren (Drug); Placebo to valsartan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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.

Official title: An Eight-week, Randomized, Double-blind, Parallel-group, Pilot Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg in Comparison With Valsartan 320 mg in Patients With Mild to Moderate Hypertension During Exercise After a Missed Dose

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose

Secondary outcome:

Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8

Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Investigative Site, Pardubice, Czech Republic

Investigative Site, Prague, Czech Republic

Investigative Site, Budapest, Hungary

Investigative Site, Nyiregyhaza, Hungary

Investigative Site, Pilisvörösvár, Hungary

Investigative Site, Szentendre, Hungary

Investigative Site, Singapore, Singapore

Investigative Site, Leicester, United Kingdom

Starting date: February 2009
Last updated: June 2, 2011