NDC0009-0436-01 ( 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4

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
Target_
size
PhaseCountries
1EUCTR2018-001989-42-SI
(EUCTR)
05/05/202205/05/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy
2EUCTR2018-001989-42-DE
(EUCTR)
02/05/202207/05/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy
3EUCTR2018-001989-42-PL
(EUCTR)
04/08/202129/06/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene 10
Product Name: Arginine Hydrochloride
Product Code: NDC0009-0436-01
INN or Proposed INN: Arginine Hydrochloride
Other descriptive name: ARGININE HYDROCHLORIDE
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
INN or Proposed INN: Clonidine hydrochloride
Other descriptive name: CLONIDINE HYDROCHLORIDE
Aeterna Zentaris GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy
4EUCTR2018-001989-42-IT
(EUCTR)
03/08/202130/08/2021A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it isMulticenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial Diagnosis of growth hormone deficiency in pediatric subjects
MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Catapresan 75
Product Name: Clonidine Hydrochloride
Product Code: [-]
INN or Proposed INN: CLONIDINA CLORIDRATO
Other descriptive name: Clonidine hydrochloride
Trade Name: Macimorelin Consilient Health
Product Name: Macimorelin
Product Code: [AEZS-130]
INN or Proposed INN: macimorelina
Other descriptive name: MACIMORELIN ACETATE
Trade Name: R-Gene
Product Name: Arginine Hydrochloride
Product Code: [NDC0009-0436-01]
INN or Proposed INN: ARGININA CLORIDRATO
Other descriptive name: ARGININE HYDROCHLORIDE
AETERNA ZENTARIS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy