Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension
Phase 2
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00160225
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks
- urinary albumin excretion ≥ 20 and < 1000 µg/min
- sitting systolic/diastolic blood pressure (SBP/DBP) < 140/90 mmHg at the end of placebo run-in phase
Exclusion Criteria
- known secondary hypertension
- decompensated congestive heart failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 1
🇮🇹Ranica, Italy