Norditropin FlexPro 5mg/1.5 ml ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
78下垂体前葉機能低下症1

78. 下垂体前葉機能低下症


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2020-000929-42-IT
(EUCTR)
18/10/202108/06/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: lonapegsomatropin drug product
Product Code: [ACP-011]
INN or Proposed INN: lonapegsomatropin
Product Name: Norditropin FlexPro 5mg/1.5 ml
Product Code: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden