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

This study has been completed.

First Received: September 12, 2005 Last Updated: June 1, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219167

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	356
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219167

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CSPP100A2324
Study First Received:	September 12, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00219167 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

hypertension
aliskiren
age

Study placed in the following topic categories:

Essential Hypertension
Lisinopril
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009