ong-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON O

Phase 1

• Conditions: The intended indication is Pulmonary Arterial Hypertension; MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension

• Registration Number: EUCTR2009-014992-31-FR
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-26
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 544

Inclusion Criteria

1. Signed informed consent form (ICF) prior to initiation of any study-mandated procedure.
2. Patients who have completed the double-blind studies AC-065A301 or AC-065A302 as scheduled per protocol,
or,
who have experienced a clinical worsening of PAH (adjudicated by the CEC) after their Week 16 assessments in AC-065A301 or AC-065A302 studies, and for whom a
written approval to be transferred into this study has been obtained from the sponsor.
3. Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after end of study treatment.
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. Any major violation of protocols AC-065A301 or AC-065A302.
2. Patients who have experienced a clinical worsening of PAH before their Week 16 assessment in study AC-065A301 or AC-065A302.
3. Females who plan to become pregnant during the study, or are breastfeeding.
4. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.
5. Known hypersensitivity to ACT-293987 or any of the excipients.

Study & Design

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