WHO ICTRP trial

An exploratory Phase 2 study to evaluate the Safety and Efficacy of CRN00808 for…

EUCTR2018-002230-20-SK · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2018-002230-20-SK
Public title An exploratory Phase 2 study to evaluate the Safety and Efficacy of CRN00808 for the treatment of acromegaly
Scientific title An open label exploratory study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly treated with somatostatin analogue based treatment regimens (ACROBAT EDGE) - ACROBAT EDGE
Primary sponsor Crinetics Pharmaceuticals, Inc.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Serbia;Hungary;Slovakia;Greece;Poland;Romania;Australia;Germany;United Kingdom;Italy
Conditions Acromegaly MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Interventions Product Name: CRN00808 Product Code: CRN00808 Pharmaceutical Form: Capsule INN or Proposed INN: not assigned yet Current Sponsor code: CRN00808.HCl Other descriptive name: CRN00808 Concentration unit: mg milligram(s) Concentration type…
Registration date Sep 14, 2018
Target size 45
Secondary IDs CRN00808-03;NCT03729555;2018-002230-20-HU
Registry page clinicaltrialsregister.eu

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