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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00219050
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 25, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: aliskiren Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2005
Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 8 weeks
  2. Change from baseline in systolic blood pressure after 8 weeks
  3. Change from baseline in standing systolic blood and diastolic pressure after 8 weeks
  4. Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Novartis Pharmaceuticals
More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00219050     History of Changes
Other Study ID Numbers: CSPP100A2303
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs