Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219037

Enrollment

1955

Registered

2005-09-22

Start date

2004-06-30

Completion date

2005-10-31

Last updated

2011-11-08

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

Conditions

Hypertension

Keywords

Hypertension, blood pressure, aliskiren

Brief summary

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with essential hypertension. 2. Patients who are eligible and able to participate in the study.

Exclusion criteria

1. Severe hypertension. 2. History or evidence of a secondary form of hypertension. 3. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Adverse events, laboratory abnormalities, serious adverse events	—

Secondary

Measure	Time frame
Change from baseline in mean sitting diastolic blood pressure after 12 months	—
Change from baseline in mean sitting systolic blood pressure after 12 months	—
Change from baseline in standing systolic blood and diastolic pressure after 12 months	—
Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline	—
Blood pressure less than 140/90 mmHg	—

Countries

Germany

Outcome results

None listed

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