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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Telmisartan; Valsartan

Criteria

Inclusion Criteria:

1. Type 2 diabetes mellitus

2. Aged 30-70 years of age

3. 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)

4. Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)

Exclusion Criteria: None