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
To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)
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 |
|---|---|---|
| Change from baseline in diastolic blood pressure after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic blood pressure after 8 weeks | ||
| Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks | ||
Not provided
Inclusion Criteria
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21659626 | Derived | Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood pressure < 140/90 mmHg |
| Change from baseline in standing diastolic blood pressure after 8 weeks |
| Change from baseline in standing systolic blood pressure after 8 weeks |
| Investigative Centers |
| Germany |
| 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