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 on September 12, 2005. Last Updated on February 24, 2011 History of Changes

Sponsor:	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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

U.S. FDA Resources

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
Study Start Date:	February 2005
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Site
Berlin, Germany
Hungary
Investigative Site
Budapest, Hungary
Spain
Investigative Site
Madrid, Spain
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00219050 History of Changes
Other Study ID Numbers:	CSPP100A2303
Study First Received:	September 12, 2005
Last Updated:	February 24, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012