A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 1, 2006

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219167 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks
Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
Blood pressure control target of < 140/90 mmHg after 8 weeks

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Official Title ^ICMJE

An 8-Week, Randomized, Double-Blind, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 Mg, 150 Mg, and 300 Mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-Hour ABPM, With Lisinopril 10 Mg as a Reference

Brief Summary

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

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

356

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Patients with at least 65 years-old
Patients with essential hypertension Exclusion Criteria
Severe hypertension
History or evidence of a secondary form of hypertension
History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00219167

Responsible Party

Study ID Numbers ^ICMJE

CSPP100A2324

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

June 2006

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