AEZS-130 ( 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9

78. 下垂体前葉機能低下症


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 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-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
2EUCTR2018-001989-42-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
3EUCTR2015-002337-22-IT
(EUCTR)
24/05/201608/06/2021Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: Macimorelin acetate
Trade Name: Humalog Mix50 100 U/ml sospensione iniettabile
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: Insulin
AETERNA ZENTARIS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy
4EUCTR2015-002337-22-PL
(EUCTR)
12/04/201601/02/2016Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom
5EUCTR2015-002337-22-DE
(EUCTR)
19/01/201609/11/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
6EUCTR2015-002337-22-AT
(EUCTR)
10/12/201530/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
7EUCTR2015-002337-22-GB
(EUCTR)
08/12/201528/10/2015Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adultsConfirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Product Name: Macimorelin
Product Code: AEZS-130
INN or Proposed INN: Macimorelin acetate
Other descriptive name: MACIMORELIN ACETATE
Product Name: Insulin
INN or Proposed INN: Insulin
Other descriptive name: INSULIN
Aeterna Zentaris GmbHNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom
8NCT00448747
(ClinicalTrials.gov)
June 200716/3/2007Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and EfficacyDiagnosis of Adult Growth Hormone Deficiency (AGDH)Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRHAEterna ZentarisNULLCompleted18 YearsN/AAll101Phase 3United States
9EUCTR2018-001989-42-DE
(EUCTR)
07/05/2021A 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 GmbHNULLNAFemale: yes
Male: yes
100Phase 3United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy