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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 7, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: aliskiren

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00219050

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CSPP100A2303

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP