A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2

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

• Registration Number: EUCTR2009-014490-41-FR
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

- Signed informed consent prior to initiation of any study-mandated procedure.
- Male and female patients 18 years of age or older with symptomatic PAH.
- Documented hemodynamic diagnosis of PAH.
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

- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 1 month before Baseline Visit, or are scheduled to
receive any of these compounds during the trial.
- Patients with moderate or severe obstructive lung disease: FEV1/FVC < 70% or FEV1 < 65% of predicted value after bronchodilator administration.
- Patients with moderate or severe restrictive lung disease:
Total Lung Capacity < 60% of predicted value.
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
- Patients with clinically-relevant left ventricular dysfunction.
- Patients with clinically-significant chronic renal insufficiency (estimated creatinine clearance < 30 mL/min, or serum creatinine > 2.5 mg/dL).
- Patients with body weight < 40 kg.

Study & Design

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