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	NCT01251835 (ClinicalTrials.gov)	December 2010	1/12/2010	Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan	A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects	Pulmonary Arterial Hypertension	Drug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: Rifampin	Pfizer	NULL	Withdrawn	21 Years	55 Years	Both	0	Phase 1	NULL
2	NCT00796666 (ClinicalTrials.gov)	May 2009	20/11/2008	Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil	A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)	Pulmonary Arterial Hypertension;Pulmonary Hypertension	Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil	Pfizer	NULL	Terminated	16 Years	80 Years	All	131	Phase 3	United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia

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

NCT01251835
(ClinicalTrials.gov)

December 2010

1/12/2010

Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects

Pulmonary Arterial Hypertension

Drug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: Rifampin

Pfizer

NULL

Withdrawn

21 Years

55 Years

Both

Phase 1

NULL

NCT00796666
(ClinicalTrials.gov)

May 2009

20/11/2008

Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

Pulmonary Arterial Hypertension;Pulmonary Hypertension

Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil

Pfizer

NULL

Terminated

16 Years

80 Years

All

131

Phase 3

United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia