Phase 3
Completed N=556
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Source: ClinicalTrials.gov NCT00402103 ↗Enrolled (actual)
556
Serious AEs
1.3%
Results posted
Jan 2011
Primary outcomePrimary: Overall Percentage of Patients With Adverse Events — 23.6; 71.2; 57.0 Percentage of Participants
Summary
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Percentage of Patients With Adverse Events |
23.6; 71.2; 57.0 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points |
-8.7; -5.9; -14.0; -11.9; -15.7; -11.5 | — |
| SECONDARY Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg |
35.3; 8.1; 88.0; 16.3; 88.2; 56.8 | — |
| SECONDARY Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) |
61.2; 38.4; 96.8; 61.6; 95.9; 85.2 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients 18 years of age or older
- Male or female patients are eligible
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
Exclusion Criteria
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00402103). 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.