Status:

COMPLETED

Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

Lead Sponsor:

Novartis

Conditions:

Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this st...

Eligibility Criteria

Inclusion

  • Mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg
  • 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg

Exclusion

  • Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
  • Patients with Type 1 diabetes mellitus
  • Secondary hypertension of any etiology
  • Other protocol-defined inclusion/exclusion criteria may apply

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

822 Patients enrolled

Trial Details

Trial ID

NCT00865020

Start Date

March 1 2009

End Date

June 1 2010

Last Update

July 22 2011

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Investigative Site

Sorocaba, Brazil

2

Investigative Site

Gatineau, Canada

3

Investigative Site

Guayaquil, Ecuador

4

Investigative Site

Erfurt, Germany