Omnitrope® (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 | 5 |
| 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 | EUCTR2010-021523-28-DE (EUCTR) | 05/10/2010 | 10/08/2010 | A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 2 | EUCTR2010-021523-28-SE (EUCTR) | 27/09/2010 | 06/08/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 3 | EUCTR2010-021523-28-DK (EUCTR) | 13/09/2010 | 29/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Austria;Denmark;Germany;Italy;Sweden | ||
| 4 | EUCTR2010-021523-28-AT (EUCTR) | 02/09/2010 | 20/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 5 | NCT01298180 (ClinicalTrials.gov) | January 2009 | 6/11/2009 | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Prader-Willi Syndrome;Growth Hormone Deficiency | Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsy | University Hospital, Toulouse | NULL | Completed | 1 Year | 5 Years | Both | 111 | Phase 4 | France |