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

Phase 2CompletedNCT00819767

Novartis68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

AliskirenDRUG

Aliskiren was supplied in 150 mg tablets.

ValsartanDRUG

Valsartan was supplied in 160 mg capsules.

Placebo to aliskirenDRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (8)

Investigative Site

Pardubice, Czechia

Investigative Site

Prague, Czechia

Investigative Site

Budapest, Hungary

Investigative Site

Nyíregyháza, Hungary

Outcomes

Primary Outcomes

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

The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.

Time frame: Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.

Secondary Outcomes

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

The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.

Time frame: Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.

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

The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.

Data from ClinicalTrials.gov

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