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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Aliskiren/ Valsartan; Drug: Telmisartan/ Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939588

CSPV100A2225

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

Aliskiren and Valsartan

Experimental group

Treatment:

Drug: Aliskiren/ Valsartan

Telmisartan and Ramipril

Active Comparator group

Treatment:

Drug: Telmisartan/ Ramipril