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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219050

Enrollment

180

Registered

2005-09-22

Start date

2005-02-28

Completion date

2005-11-30

Last updated

2011-02-25

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

Conditions

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

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Evaluate safety through adverse events and laboratory abnormalities after 8 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Germany, Hungary, Spain, Switzerland

Outcome results

None listed

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