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
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
- Diabetic Nephropathies
- Hypertension
Interventions
- DRUG
-
Telmisartan
- DRUG
-
Valsartan
Sponsors & Collaborators
- lead INDUSTRY
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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