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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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00219050

Investigative Site
Berlin, Germany
Investigative Site
Budapest, Hungary
Investigative Site
Madrid, Spain
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00219050     History of Changes
Other Study ID Numbers: CSPP100A2303
Study First Received: September 12, 2005
Last Updated: February 24, 2011

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 19, 2017