193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details
臨床試験数 : 113 / 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102
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 |
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1 | EUCTR2021-000127-12-SE (EUCTR) | 03/01/2022 | 08/11/2021 | A 16-week phase 2b, double-blind, placebo-controlled, Multi center, dose finding safety and efficacy study to evaluate overall safety and tolerability of Tesomet ( tesofensine and metoprolol) in subjects with Prader-Willi Syndrome, and with an optional 38-week open-label extension | A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects with Prader-Willi Syndrome | Prader-Willi Syndrome MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) | Saniona A/S | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden |