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) - ND
Phase 1
- Conditions
- Pulmonary Arterial Hypertension (PHA) (idiopatic PAH, familiar PHA, and associated with collagen disease, corrected congenital vitium or anorexigen)MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionMedDRA version: 9.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionMedDRA version: 9.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionMedDRA version: 9.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
- Registration Number
- EUCTR2007-006453-12-IT
- Lead Sponsor
- IPPON SHINYAKU CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
The main criteria for inclusion are subjects who have completed the NS 304/-02 study and have signed informed consent for participation in this 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
? Subjects with medically abnormal findings (ECG, physical examination, AEs) at the end of Visit 7 (Week 17) of the preceding double-blind study that the Investigator considers not appropriate to enter this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the open-extension study is to collect and evaluate long-term safety and tolerability data of NS-304 treatment in subjects with pulmonary arterial hypertension (PAH).;Secondary Objective: The secondary objectives of the open-extension study are: - Assessments of efficacy of NS-304 regarding the following variable: o 6-minute walk test (6MWT). The tertiary objectives of the open-extension study are: - Assessments of efficacy of NS-304 regarding the following variables: o Time to aggravation of PAH. o Proportion of subjects with aggravation of PAH o Borg dyspnoea score. o New York Heart Association (NYHA) functional class. o Plasma brain natriuretic peptide (BNP) concentrations.;Primary end point(s): Safety assessments is the primary end point: vital signs (blood pressure, pulse rate); treatment emergent AEs; clinical laboratory data (hematology, blood chemistry and urinalysis); physical examination and 12 lead electrocardiogram (ECG) parameters.
- Secondary Outcome Measures
Name Time Method