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To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diastolic blood pressure after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic blood pressure after 12 weeks | ||
| Change from baseline in systolic and diastolic blood pressure after 6 weeks | ||
| Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks |
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Inclusion Criteria
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Salisbury | North Carolina | 28144 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21846154 | Derived | Drummond W, Sirenko YM, Ramos E, Baek I, Keefe DL. Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 10.2165/11591970-000000000-00000. |
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| Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks |
| Kortrijk |
| Belgium |
| Investigative Site | Bucharest | Romania |
| Investigative Site | Madrid | Spain |
| Investigative Site | Stockholm | Sweden |
| Novartis Pharmaceuticals | Basel | Switzerland |
| Investigative Site | Kiev | Ukraine |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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