| October 10, 2006 |
| December 5, 2008 |
| October 2006 |
| March 2008 (final data collection date for primary outcome measure) |
- Assess long-term safety of the combination of aliskiren 300 mg/valsartan 320 mg in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mgHg). [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
- 2. Assess the safety and tolerability of the triple combination of aliskiren/valsartan/HCTZ (SVH) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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| Safety of aliskiren and valsartan for 54 weeks |
| Complete list of historical versions of study NCT00386607 on ClinicalTrials.gov Archive Site |
- 1. To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/valsartan [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The proportion of patients achieving the blood pressure target of <140/90 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To assess the long-term blood pressure lowering efficacy of the triple combination of aliskiren/valsartan/HCTZ. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of the 6 month extension study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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- Mean sitting diastolic blood pressure (msDBP) lowering efficacy of the combination of aliskiren and valsartan from baseline to week 54
- Achieving blood pressure control target of <140/90 mmHg at end of study
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| |
| A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-Term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. |
| 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. |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Hypertension |
| Drug: Aliskiren/valsartan/HCTZ combination |
| Experimental: Aliskiren/valsartan/HCTZ |
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| |
| Completed |
| 601 |
|
| March 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria: -
- Male and female outpatients 18 years of age and older.
- Patients who are eligible and able to participate in the study.
Patients will qualify to participate in the long-term extension based on:
- Their successful completion of the CSPV100A2301 Core study.
- Obtaining informed consent to participate in the extension study.
- Absence of ongoing severe adverse events at final visit in core study.
- Absence of hypotension (msSBP <100 mmHg or msDBP (<60 mmHg) or related events at final visit in the core study.
- Absence of hypokalemia (clinical symptoms/signs or lab findings) at Visits 12 or 13.
Exclusion Criteria:
- Severe hypertension.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined inclusion/exclusion criteria may apply. |
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Germany |
| |
| NCT00386607 |
| External Affairs, Novartis |
| CSPV100A2301 |
| Novartis |
|
| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
|
|
| Novartis |
| December 2008 |