Status:
COMPLETED
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
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.
Eligibility Criteria
Inclusion
- 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
- known secondary hypertension
- decompensated congestive heart failure
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00160225
Start Date
July 1 2005
Last Update
November 14 2007
Active Locations (1)
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1
Site 1
Ranica, Italy