A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00260923

Enrollment

641

Registered

2005-12-02

Start date

2005-11-30

Completion date

2006-11-30

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

Brief summary

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Male and female outpatients 18 years of age and older * 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 inclusion/

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 8 weeks	—

Countries

Germany, United States

Outcome results

None listed

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