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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

Phase 3
Completed
Conditions
Hypertension
Registration Number
NCT00294710
Lead Sponsor
Novartis
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
976
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 exclusion criteria also apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in diastolic blood pressure after 52 weeks
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Novartis

🇺🇸

East Hanover, New Jersey, United States

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