A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

Phase 3CompletedNCT00219050

Novartis180 enrolled

Overview

To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with essential severe hypertension Exclusion Criteria * History or evidence of a secondary form of hypertension * History of hypertensive encephalopathy or cerebrovascular accident. * Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply

Locations (4)

Investigative Site

Berlin, Germany

Investigative Site

Budapest, Hungary

Investigative Site

Madrid, Spain

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Change from baseline in systolic blood pressure after 8 weeks

Change from baseline in standing systolic blood and diastolic pressure after 8 weeks

Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

Data from ClinicalTrials.gov

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