A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 With Once Weekly Dosing of Placebo and Daily Norditropin FlexPro in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Trial Profile

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 With Once Weekly Dosing of Placebo and Daily Norditropin FlexPro in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2017

At a glance

  • Drugs Somapacitan (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms REAL 1
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 20 Sep 2017 Planned End Date changed from 6 May 2018 to 7 May 2018.
    • 28 Feb 2017 Planned End Date changed from 1 May 2018 to 7 May 2018.
    • 27 Dec 2016 Planned primary completion date changed from 1 May 2018 to 1 May 2017.
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