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

A Twenty Six-week, 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
NCT00294710
Enrollment
976
Registered
2006-02-22
Start date
2005-03-31
Completion date
2006-07-31
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, aliskiren, hydrochlorothiazide, amlodipine

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

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
Change from baseline in diastolic blood pressure after 52 weeks—

Secondary

MeasureTime frame
Change from baseline in systolic and diastolic blood pressure after 52 weeks—
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks—
Achieve blood pressure control target of < 140/90 mmHg after 12 weeks—

Countries

Germany, United States

Outcome results

None listed

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