193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103

  
3 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2021-000127-12-SE
(EUCTR)
03/01/202208/11/2021A 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 extensionA 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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden
2EUCTR2016-003694-18-CZ
(EUCTR)
18/01/201704/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) Second 12 weeks open label extension Prader Willi syndrome (PWS)
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: Tesofensine
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
Trade Name: Metoprololsuccinat ”Orion” 25mg
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Saniona A/SNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Hungary;Czech Republic
3EUCTR2016-003694-18-HU
(EUCTR)
22/12/201613/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) A 12 weeks open label extension Prader Willi syndrome (PWS)
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: Tesofensine
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
Trade Name: Metoprololsuccinat Orion 25mg
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Saniona A/SNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary