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

NCT00153023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 885

Last updated 2013-11-13

No results posted yet for this study

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 of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

Conditions

Interventions

DRUG

Telmisartan

DRUG

Valsartan

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · B.I. Pharma GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Malaysia
  • Portugal
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153023 on ClinicalTrials.gov