Macrilen ( 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 | 2 |
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 | EUCTR2018-001988-23-PL (EUCTR) | 19/04/2019 | 23/01/2019 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Belarus;Hungary;Poland;Ukraine;Russian Federation | ||
| 2 | EUCTR2018-001988-23-HU (EUCTR) | 07/11/2018 | 05/09/2018 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Ukraine;Russian Federation |