An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Study Overview
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Brief Summary
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To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).

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 / Amlodipine 10 mg in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Drug: Amlodipine
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients 18 years of age or older Male or female patients are eligible 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) 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

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: Aliskiren/Amlodipine<br> | Drug: Aliskiren<br>* All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration<br>Drug: Amlodipine<br>* All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration<br>|
| Experimental: Aliskiren/Amlodipine/HCTZ<br> | Drug: Aliskiren<br>* All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration<br>Drug: Amlodipine<br>* All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration<br>Drug: Hydrochlorothiazide<br>* Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.<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 |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points |  | Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54 | 
| Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg |  | Baseline, Week 2, Week 10, Week 28 and Week 54 | 
| Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) |  | Baseline, Week 2, Week 10, Week 28 and Week 54 | 

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