An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy

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

Summary

This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• Written informed consent for participation before the completion of MT-3995-J05 Study

• Completion of MT-3995-J05 study

Exclusion Criteria:

• UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study

• Symptomatic and clinically significant hypotension

• QT prolongation or torsades de pointes

• New York Heart Association (NYHA) Class III or IV heart failure

• Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study