A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

Phase 1

• Conditions: pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen; MedDRA version: 9.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension; MedDRA version: 9.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension; MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension; MedDRA version: 9.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension

• Registration Number: EUCTR2007-006453-12-FR
• Lead Sponsor: ippon Shinyaku Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Subjects who have completed the preceding double-blind study (NS-304/-02)
2) Subjects who have signed informed consent for participation in the open-extension study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects with medically abnormal findings (ECG, physical examination, AEs) at the end of visit 7 of the preceding double-blind study that investigators considers not appropriate to enter this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified