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	NCT01094067 (ClinicalTrials.gov)	September 1, 2010	25/3/2010	Tezosentan in Patients With Pulmonary Arterial Hypertension	Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.	Pulmonary Arterial Hypertension	Drug: ACT-050089;Other: Placebo	Idorsia Pharmaceuticals Ltd.	NULL	Terminated	18 Years	N/A	All	2	Phase 2	United States;France;Japan
2	EUCTR2009-012450-20-FR (EUCTR)	15/10/2009	07/09/2009	Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines	Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines	Pulmonary arterial hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Tezosentan Product Code: ACT-050089 (Ro 61-0612) INN or Proposed INN: tezosentan Other descriptive name: Tezosentan	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	13	Phase 2a	France

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

NCT01094067
(ClinicalTrials.gov)

September 1, 2010

25/3/2010

Tezosentan in Patients With Pulmonary Arterial Hypertension

Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.

Pulmonary Arterial Hypertension

Drug: ACT-050089;Other: Placebo

Idorsia Pharmaceuticals Ltd.

NULL

Terminated

18 Years

N/A

All

Phase 2

United States;France;Japan

EUCTR2009-012450-20-FR
(EUCTR)

15/10/2009

07/09/2009

Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines

Pulmonary arterial hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: Tezosentan
Product Code: ACT-050089 (Ro 61-0612)
INN or Proposed INN: tezosentan
Other descriptive name: Tezosentan

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2a

France