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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 7, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219050

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Lisinopril Aliskiren

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:

180

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219050

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2303
Study First Received:	September 12, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00219050 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lisinopril
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009