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The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months | ||
| Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | East Hanover | New Jersey | United States | |||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22035463 | Result | 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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| Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months |
| Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline |
| Blood pressure less than 140/90 mmHg |
| Deurne |
| Belgium |
| Investigative Site | Ste-Fov | Canada |
| Investigative Site | Krassel | Germany |
| Investigative Site | Broni | Italy |
| Investigative Site | Rotterdam | Netherlands |
| Investigative Site | Lima | Peru |
| Investigative Site | Moscow | Russia |
| Investigative Site | Basel | Switzerland |
| Investigative Site | London | United Kingdom |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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