DDrare: Database of Drug Development for Rare Diseases

Remodulin® (treprostinil) 2.5 mg/ml solution for infusion (DrugBank: Treprostinil)

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	1

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	EUCTR2011-004631-31-DE (EUCTR)	13/03/2012	10/02/2012	16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin®	A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15	United Therapeutics Corp.	NULL	Not Recruiting			Female: yes Male: yes	50		Germany

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

EUCTR2011-004631-31-DE
(EUCTR)

13/03/2012

10/02/2012

16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin®

A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study

Pulmonary Arterial Hypertension (PAH)
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15

United Therapeutics Corp.

NULL

Not Recruiting

Female: yes
Male: yes

Germany