Phase 2 N=68 Randomized Double-blind Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00819767 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose — 2.58; 8.26 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aliskiren (Drug); Valsartan (Drug); Placebo to aliskiren (Drug); Placebo to valsartan (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose	2.58; 8.26	—
SECONDARY Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8	5.78; 7.79	—
SECONDARY 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	-4.16; 1.37	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00819767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.