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

Condition(s) targeted: Hypertension

Intervention: aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

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

Secondary outcome:

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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: April 2005
Last updated: June 1, 2006