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
86	肺動脈性肺高血圧症	2

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	NCT00866983 (ClinicalTrials.gov)	October 2009	20/3/2009	Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil	A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.	Pulmonary Arterial Hypertension	Drug: sildenafil (Revatio) 20 mg TID	Pfizer	NULL	No longer available	18 Years	N/A	Both		Phase 4	Brazil
2	EUCTR2006-004705-26-GB (EUCTR)	10/05/2007	17/04/2007	Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology	Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology	Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease) MedDRA version: 8.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome	Trade Name: Revatio ® 20 mg film-coated tablets Product Name: Sildenafil INN or Proposed INN: Sildenafil (REVATIO)	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 4	United Kingdom

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

NCT00866983
(ClinicalTrials.gov)

October 2009

20/3/2009

Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.

Pulmonary Arterial Hypertension

Drug: sildenafil (Revatio) 20 mg TID

Pfizer

NULL

No longer available

18 Years

N/A

Both

Phase 4

Brazil

EUCTR2006-004705-26-GB
(EUCTR)

10/05/2007

17/04/2007

Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology

Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
MedDRA version: 8.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome

Trade Name: Revatio ® 20 mg film-coated tablets
Product Name: Sildenafil
INN or Proposed INN: Sildenafil (REVATIO)

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom