Tesomet ( DrugBank: - )


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2

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
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/SNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden
2NCT05198362
(ClinicalTrials.gov)
December 28, 20215/1/2022Study of Tesomet With Open-label Extension in Subjects With Prader-Willi SyndromeA Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi SyndromePrader-Willi SyndromeOther: Placebo;Drug: TesometSanionaNULLWithdrawn13 Years65 YearsAll0Phase 2United States