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	NCT00325403 (ClinicalTrials.gov)	October 2006	11/5/2006	FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension	Pulmonary Hypertension	Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo	United Therapeutics	NULL	Completed	12 Years	75 Years	All	349	Phase 3	United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico
2	NCT00325442 (ClinicalTrials.gov)	October 2006	11/5/2006	FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension	Pulmonary Hypertension	Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo	United Therapeutics	NULL	Completed	12 Years	70 Years	All	354	Phase 3	United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;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

NCT00325403
(ClinicalTrials.gov)

October 2006

11/5/2006

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

Pulmonary Hypertension

Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo

United Therapeutics

NULL

Completed

12 Years

75 Years

All

349

Phase 3

United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico

NCT00325442
(ClinicalTrials.gov)

October 2006

11/5/2006

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension

Pulmonary Hypertension

Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo

United Therapeutics

NULL

Completed

12 Years

70 Years

All

354

Phase 3

United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom