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

Condition(s) targeted: Hypertension

Intervention: aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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

Official title: An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Investigative Site, Berlin, Germany

Investigative Site, Budapest, Hungary

Investigative Site, Madrid, Spain

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: February 2005
Last updated: February 24, 2011