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	3

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	NCT02276872 (ClinicalTrials.gov)	December 18, 2014	21/10/2014	Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years	A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension	PAH	Drug: oral treprostinil	United Therapeutics	NULL	Completed	7 Years	17 Years	All	32	Phase 2	United States
2	NCT01266265 (ClinicalTrials.gov)	December 2010	22/12/2010	Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies	A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution	Pulmonary Arterial Hypertension	Drug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitors	United Therapeutics	NULL	Completed	N/A	N/A	All	1333	N/A	United States
3	NCT01268553 (ClinicalTrials.gov)	August 2010	29/12/2010	Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication	Transition From Parenteral Prostanoids to Inhaled Treprostinil	Pulmonary Arterial Hypertension	Drug: Treprostinil	Los Angeles Biomedical Research Institute	United Therapeutics	Completed	18 Years	80 Years	All	6	Phase 4	United States

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

NCT02276872
(ClinicalTrials.gov)

December 18, 2014

21/10/2014

Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years

A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension

PAH

Drug: oral treprostinil

United Therapeutics

NULL

Completed

7 Years

17 Years

All

Phase 2

United States

NCT01266265
(ClinicalTrials.gov)

December 2010

22/12/2010

Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Pulmonary Arterial Hypertension

Drug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitors

United Therapeutics

NULL

Completed

N/A

All

1333

N/A

United States

NCT01268553
(ClinicalTrials.gov)

August 2010

29/12/2010

Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Transition From Parenteral Prostanoids to Inhaled Treprostinil

Pulmonary Arterial Hypertension

Drug: Treprostinil

Los Angeles Biomedical Research Institute

United Therapeutics

Completed

18 Years

80 Years

All

Phase 4

United States