A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219128

Enrollment

671

Registered

2005-09-22

Start date

2004-11-30

Completion date

2005-06-30

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, aliskiren, blood pressure, placebo

Brief summary

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential 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 hypertension * Patients who are eligible and able to participate in the study

Exclusion criteria

* Severe hypertension * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in systolic blood pressure after 8 weeks	—
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks	—
Blood pressure <140/90 mmHg after 4 weeks and 8 weeks	—
Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks	—
Evaluate high and low level drug effect using 24 hour blood pressure monitoring	—

Countries

United States

Outcome results

None listed

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