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.
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|ClinicalTrials.gov Identifier: NCT00386607|
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : May 10, 2011
Last Update Posted : February 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Aliskiren Drug: Valsartan Drug: Hydrochlorothiazide (HCTZ)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||601 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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/Hydrochlorothiazide(HCTZ)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Aliskiren 300 mgDrug: Valsartan
Valsartan 320 mg
Experimental: Extension Treatment
For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.
Aliskiren 300 mgDrug: Valsartan
Valsartan 320 mgDrug: Hydrochlorothiazide (HCTZ)
Hydrochlorothiazide (HCTZ) 12.5-25 mg
- Overall Percentage of Patients With Adverse Events [ Time Frame: Month 12 ]
- Overall Percentage of Patients With Adverse Events [ Time Frame: Month 18 ]adverse event data obtained from both the core study and the 6 month extension study.
- Change From Baseline in Mean Sitting Diastolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]
- Change From Baseline in Mean Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54 ]
- Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg [ Time Frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]
- Change From Baseline in Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
- Change From Baseline in Mean Sitting Systolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
- Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment [ Time Frame: Month 18 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386607
|United States, California|
|San Diego, California, United States|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|