Tesofensine/Metoprolol ( DrugBank: Metoprolol, Tesofensine )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
193プラダー・ウィリ症候群3

193. プラダー・ウィリ症候群


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03149445
(ClinicalTrials.gov)
March 30, 20173/4/2017Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)A 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)Confirmed Genetic Diagnosis of Prader-Willi SyndromeDrug: Tesofensine/Metoprolol;Drug: PlacebosSanionaNULLCompleted18 Years30 YearsAll18Phase 2Czechia
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