Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting systolic blood pressure after 8 weeks | ||
| Change from baseline in mean sitting diastolic blood pressure after 8 weeks | ||
| Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | Japan | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19927154 | Result | Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C446481 | aliskiren |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks |
| Blood pressure <140/90 after 8 weeks |