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

February 24, 2011 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 25, 2011

Last Update Submitted That Met QC Criteria

February 24, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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