DDrare: Database of Drug Development for Rare Diseases

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

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
1	EUCTR2009-011535-12-SE (EUCTR)	24/06/2009	10/06/2009	To 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-201	Open-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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110		Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden

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

EUCTR2009-011535-12-SE
(EUCTR)

24/06/2009

10/06/2009

To 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-201

Open-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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

110

Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden