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 and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension
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 |
|---|---|---|
| Incidence of adverse events after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks | ||
| Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | Japan | Japan |
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
| Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks. |