A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine

A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219154

Enrollment

1125

Registered

2005-09-22

Start date

2005-03-31

Completion date

2006-01-31

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

Brief summary

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine 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

Exclusion criteria

* Severe hypertension * History or evidence of a secondary form of hypertension * History of myocardial infarction. Other protocol-defined inclusion

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure after 26 weeks	—

Secondary

Measure	Time frame
Change from baseline systolic blood pressure after 26 weeks	—
Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 26 weeks	—
Achieve blood pressure of < 140/90 mmHg after 26 weeks	—

Countries

Germany, Switzerland

Outcome results

None listed

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