Clinical Trial: A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Do
Brief Summary: The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome:
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. [ Time Frame: up to 8 weeks ]
- Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: up to 16 weeks ]
Original Primary Outcome:
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. [ Time Frame: up to 8 weeks ]
- Safety and tolerability assessed by adverse events, vital signs, clinical laboratory examinations and 12-lead electrocardiogram [ Time Frame: up to 16 weeks ]
Current Secondary Outcome:
- Percentage change from baseline in UACR compared to placebo [ Time Frame: up to 8 weeks ]
- Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. [ Time Frame: up to 8 weeks ]
- Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: up to 16 weeks ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: December 20, 2012
Date Started: November 2012
Date Completion:
Last Updated: February 5, 2015
Last Verified: February 2015
