Phase 2
Completed N=68
Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise
Source: ClinicalTrials.gov NCT00819767 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: 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
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.
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 | — |
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.
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. Informational only — not medical advice.