Compare the Effect of Aliskiren Plus Valsartan Versus Angiotensin-Converting Enzyme Inhibitor (ACEi) Plus Angiotensin Receptor Blocker (ARB) [Ramipril Plus Telmisartan] on the Renin-Angiotensin-Aldosterone System (RAAS) in Hypertensive Patients

Study Overview
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Brief Summary
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This study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate hypertension.

Official Title
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An 8 Week, Double-blind, Randomized, Parallel-group Study to Compare the Effect of Aliskiren 300mg + Valsartan 320mg vs. Telmisartan 80mg + Ramipril 10mg on Biomarkers of the Renin-angiotensin-aldosterone System in Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Aliskiren/ Valsartan
* Drug: Telmisartan/ Ramipril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females of non-childbearing potential, 18 to 65 years of age with moderate hypertension Patients who are eligible and able to participate in the study Exclusion criteria: Severe hypertension or secondary form of hypertension. Serum potassium > 5.1 mEq/L (mmol/L) Heart failure Any history of hypertensive encephalopathy or cerebrovascular accident; any history of TIA, myocardial infarction, coronary bypass surgery or percutaneous coronary intervention Uncontrolled or life-threatening arrythmia Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren and Valsartan<br> | Drug: Aliskiren/ Valsartan<br> <br> |
| Active Comparator: Telmisartan and Ramipril<br> | Drug: Telmisartan/ Ramipril<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II |  | 56 days | 
| Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure |  | 56 days | 
| Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan |  | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aliskiren,, hypertension,, renin-angiotensin-aldosterone system