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. | 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-SI (EUCTR) | 05/05/2022 | 05/05/2021 | 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 | 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 | ||
| 2 | EUCTR2018-001989-42-DE (EUCTR) | 02/05/2022 | 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 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |