Tafamidis meglumine 20 mg soft gelatin capsules ( DrugBank: Meglumine, Gelatin, Tafamidis )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス1

28. 全身性アミロイドーシス


臨床試験数 : 261 薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-011535-12-SE
(EUCTR)
24/06/200910/06/2009To obtain additional long-term, safety and efficacy data for tafamidis in subjects with transthyretin (TTR) familial amyloid polyneuropathy (TTR-FAP) and to continue to provide the Tafamidis to subjects with TTR-FAP who have completed Protocol Fx-006 or Protocol Fx1A-201Open-Label Safety and Efficacy Evaluation of Fx-1006A in Subjects with Transthyretin (TTR) Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Clinical trial image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Commerical image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden