Clinical Trial: Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 (Low Dose) in Subjects With Diabetic Nephropathy
Brief Summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: 20 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Plasma concentrations of MT-3995 [ Time Frame: 20 weeks ]
- Plasma concentrations of major metabolite of MT-3995 [ Time Frame: 20 weeks ]
- Change from baseline in Urine albumin-to-creatinine ratio (UACR) [ Time Frame: 20 weeks ]
- Change from baseline in blood pressure [ Time Frame: 20 weeks ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: July 27, 2014
Date Started: July 2014
Date Completion:
Last Updated: September 14, 2015
Last Verified: September 2015
