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Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Pivotal Study Assessing the Efficacy and Safety of 15 mg Twice a Day (BID) of SER150 in Well-controlled Type 2 Diabetic Patients With Diabetic Kidney Disease and Macroalbuminuria in Treatment With an Angiotensin Converting Enzyme Inhibitor or an Angiotensin Receptor Antagonist

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Trial Profile

Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Pivotal Study Assessing the Efficacy and Safety of 15 mg Twice a Day (BID) of SER150 in Well-controlled Type 2 Diabetic Patients With Diabetic Kidney Disease and Macroalbuminuria in Treatment With an Angiotensin Converting Enzyme Inhibitor or an Angiotensin Receptor Antagonist

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 Nov 2023

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At a glance

  • Drugs SER 150 (Primary)
  • Indications Diabetic nephropathies
  • Focus Registrational; Therapeutic Use
  • Sponsors Serodus
  • Most Recent Events

    • 02 Nov 2022 According to ClinicalTrials.gov record, protocol has been amended to increase patient number from 100 to 110, time frame of primary endpoint changed from Baseline, Day 84 to Baseline, Day 84 and Day 168.
    • 02 Nov 2022 Planned number of patients changed from 100 to 110.
    • 02 Nov 2022 Planned End Date changed from 15 Jun 2023 to 26 Jan 2025.
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