Clinical trial NCT00819767: Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
systolic blood pressure
exercise test
cardiovascular disease
aliskiren
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose
timeFrame: 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:
measure: Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8
timeFrame: Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.
measure: 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
timeFrame: Week 8 (Last dose; end of active treatment) 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.
Other outcomes:
Locations:
city: Pardubice
country: Czech Republic
facility: Investigative Site
city: Prague
country: Czech Republic
facility: Investigative Site
city: Budapest
country: Hungary
facility: Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Investigative Site
city: Pilisvörösvár
country: Hungary
facility: Investigative Site
city: Szentendre
country: Hungary
facility: Investigative Site
city: Singapore
country: Singapore
facility: Investigative Site
city: Leicester
country: United Kingdom
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: