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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219167

Enrollment

355

Registered

2005-09-22

Start date

2005-04-30

Completion date

2006-02-28

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, aliskiren, age

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

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026