MACIMORELIN ACETATE ( DrugBank: Macimorelin, Acetate )


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12

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
3NCT04786873
(ClinicalTrials.gov)
November 16, 20213/3/2021A 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)Growth Hormone DeficiencyDrug: Macimorelin;Diagnostic Test: Arginine;Diagnostic Test: ClonidineAEterna ZentarisNovo Nordisk A/SRecruiting2 Years17 YearsAll100Phase 3United States;Georgia;Germany;Italy;Poland;Romania;Serbia;Slovenia
4EUCTR2018-001989-42-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
5EUCTR2018-001989-42-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
6EUCTR2018-001988-23-PL
(EUCTR)
19/04/201923/01/2019A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD)Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) Diagnosis of Growth Hormone Deficiency
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: Macrilen
Product Name: macimorelin
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Belarus;Hungary;Poland;Ukraine;Russian Federation
7EUCTR2018-001988-23-HU
(EUCTR)
07/11/201805/09/2018A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD)Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) Diagnosis of Growth Hormone Deficiency
MedDRA version: 20.0;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: Macrilen
Product Name: macimorelin
INN or Proposed INN: macimorelin
Other descriptive name: MACIMORELIN ACETATE
Aeterna Zentaris GmbHNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Russian Federation;Hungary;Ukraine;Poland;Serbia
8EUCTR2015-002337-22-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 GMBHNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy
9EUCTR2015-002337-22-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
10EUCTR2015-002337-22-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
11EUCTR2015-002337-22-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
12EUCTR2015-002337-22-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