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.

Study Overview
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Brief Summary
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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/Hydrochlorothiazide(HCTZ).

Official Title
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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)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Drug: Valsartan
* Drug: Hydrochlorothiazide (HCTZ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Male and female outpatients 18 years of age and older. For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4 For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4) Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent). Exclusion Criteria: Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception. History or evidence of a secondary form of hypertension. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core Treatment<br>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. | Drug: Aliskiren<br>* Aliskiren 300 mg<br>Drug: Valsartan<br>* Valsartan 320 mg<br>|
| Experimental: Extension Treatment<br>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. | Drug: Aliskiren<br>* Aliskiren 300 mg<br>Drug: Valsartan<br>* Valsartan 320 mg<br>Drug: Hydrochlorothiazide (HCTZ)<br>* Hydrochlorothiazide (HCTZ) 12.5-25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Percentage of Patients With Adverse Events |  | Month 12 | 
| Overall Percentage of Patients With Adverse Events | adverse event data obtained from both the core study and the 6 month extension study. | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure. |  | Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 | 
| Change From Baseline in Mean Sitting Systolic Blood Pressure. |  | 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 |  | .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 | 
| Change From Baseline in Mean Sitting Diastolic Blood Pressure |  | Baseline and Month 18 | 
| Change From Baseline in Mean Sitting Systolic Blood Pressure |  | Baseline and Month 18 | 
| Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment |  | Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, aliskiren, valsartan, HCTZ, blood pressure