Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Official Title
-----------------
A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Amlodipine 10 mg
* Drug: Aliskiren 150
* Drug: Amlodipine 300


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2 Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2 All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization) Exclusion Criteria: Severe hypertension Pregnant or nursing (lactating) women Pre-menopausal women not taking accepted form of birth control Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1 History of cardiovascular conditions Uncontrolled Type 1 or Type 2 diabetes mellitus Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine 10 mg<br>Amlodipine 10 mg | Drug: Amlodipine 10 mg<br>* Amlodipine 10 mg<br>|
| Experimental: Aliskiren/Amlodipine 150/10 mg<br>Aliskiren/Amlodipine 150/10 mg | Drug: Amlodipine 10 mg<br>* Amlodipine 10 mg<br>Drug: Aliskiren 150<br>* Aliskiren/Amlodipine 150/10 mg<br>|
| Experimental: Aliskiren/Amlodipine 300/10 mg<br>Aliskiren/Amlodipine 300/10 mg | Drug: Amlodipine 10 mg<br>* Amlodipine 10 mg<br>Drug: Amlodipine 300<br>* Aliskiren/Amlodipine 300/10 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study |  | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study |  | Baseline and Week 8 | 
| Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group |  | 8 weeks | 
| Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aliskiren, Amlodipine, Non-responder to Amlodipine