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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00386607 |
Purpose
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/HCTZ.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren/valsartan/HCTZ combination |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-Label Extension to Assess the Long-Term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/HCTZ. |
| Enrollment: | 601 |
| Study Start Date: | October 2006 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Aliskiren/valsartan/HCTZ
|
Drug: Aliskiren/valsartan/HCTZ combination
Aliskiren 300 mg/ Valsartan 320 mg/ HCTZ (12.5-25 mg)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: -
Patients will qualify to participate in the long-term extension based on:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations| United States, New Jersey | |
| Novartis Pharmaceuticals, various sites | |
| East Hanover, New Jersey, United States, 07936 | |
| Canada | |
| Investigative Centers | |
| Canada, Canada | |
| Germany | |
| Investigative Centers | |
| Germany, Germany | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CSPV100A2301 |
| Study First Received: | October 10, 2006 |
| Last Updated: | December 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00386607 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
|
Hypertension, aliskiren, valsartan, HCTZ, blood pressure |
|
Essential Hypertension Vascular Diseases Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Valsartan Hypertension |
|
Therapeutic Uses Vascular Diseases Cardiovascular Diseases Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Valsartan Hypertension |