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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Losartan

Criteria

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