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

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren/ Valsartan; Drug: Telmisartan/ Ramipril

• Registration Number: NCT00939588
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Primary Completion: 2009-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren and Valsartan	Aliskiren/ Valsartan	-
Telmisartan and Ramipril	Telmisartan/ Ramipril	-

Primary Outcome Measures

Name	Time	Method
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone	56 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Moscow, Russian Federation