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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-001989-42-PL (EUCTR) | 04/08/2021 | 29/06/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, 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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy | ||
| 2 | EUCTR2018-001989-42-IT (EUCTR) | 03/08/2021 | 30/08/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, 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 GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2015-002337-22-IT (EUCTR) | 24/05/2016 | 08/06/2021 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2015-002337-22-PL (EUCTR) | 12/04/2016 | 01/02/2016 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not 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): no | Serbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2015-002337-22-DE (EUCTR) | 19/01/2016 | 09/11/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2015-002337-22-AT (EUCTR) | 10/12/2015 | 30/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2015-002337-22-GB (EUCTR) | 08/12/2015 | 28/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory 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 GmbH | NULL | Not 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): no | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 8 | NCT00448747 (ClinicalTrials.gov) | June 2007 | 16/3/2007 | Investigation 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 Efficacy | Diagnosis of Adult Growth Hormone Deficiency (AGDH) | Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRH | AEterna Zentaris | NULL | Completed | 18 Years | N/A | All | 101 | Phase 3 | United States |
| 9 | EUCTR2018-001989-42-DE (EUCTR) | 07/05/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, 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 GmbH | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy |