Status:

COMPLETED

1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Diabetic Nephropathies

Hypertension

Eligibility:

All Genders

30-80 years

Phase:

PHASE4

Brief Summary

The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target o...

Detailed Description

This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy. After...

Eligibility Criteria

Inclusion

  • Type 2 diabetes mellitus
  • Aged 30-70 years of age
  • Hypertension at screening defined as:
  • an average cuff systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \>80 mmHg in untreated patients OR
  • patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension)
  • Overt nephropathy defined by 24 hour proteinuria \>= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)

Exclusion

  • None

Key Trial Info

Start Date :

April 1 2003

Trial Type :

INTERVENTIONAL

End Date :

December 1 2005

Estimated Enrollment :

885 Patients enrolled

Trial Details

Trial ID

NCT00153023

Start Date

April 1 2003

End Date

December 1 2005

Last Update

November 13 2013

Active Locations (111)

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Page 1 of 28 (111 locations)

1

University Hospital St. Anna

Brno, Czechia, 656 91

2

University Hospital Hradec Kralove

Hradec Králové, Czechia, 500 05

3

University Hospital Vihohrady

Prague, Czechia, 100 34

4

General University Hospital

Prague, Czechia, 128 08