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Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory abnormalities, serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting diastolic blood pressure after 12 months | ||
| Change from baseline in mean sitting systolic blood pressure after 12 months | ||
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Sites | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22035463 | Derived | Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| Change from baseline in standing systolic blood and diastolic pressure after 12 months |
| Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline |
| Blood pressure less than 140/90 mmHg |