Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: iloprost; iloprost
Intervention description: Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.; Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
Intervention MeSH terms: Iloprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pulmonary arterial hypertension; inhaled treatment; inhalation solution; iloprost; Ventavis

Summary:

      Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial
      hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or
      currently being treated with a stable dose of either bosentan or sildenafil and who complete
      PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12
      week), randomized study to compare the safety and tolerability of inhaled iloprost power
      disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH).
      After completion of the double blind period, patients will be entered in the open label
      period using iloprost power disc-15.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to initiation of any study mandated procedure,

          2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in
             NYHA functional class II to IV who have completed study AC-063A301,

          3. Women of childbearing potential must have a negative urine pregnancy test and must use
             an adequate method of contraception during the study and for 28 days after
             discontinuation of the study drug.

        Exclusion Criteria:

          1. Pulmonary arterial hypertension related to any condition other than those specified in
             the inclusion criteria,

          2. Pulmonary arterial hypertension associated with significant venous or capillary
             involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg), known pulmonary
             veno-occlusive disease, or pulmonary capillary hemangiomatosis,

          3. Moderate to severe obstructive lung disease: forced expiratory volume in 1
             second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after
             bronchodilator administration,

          4. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of
             predicted value,

          5. Pregnant or breast-feeding women,

          6. Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure
             > 100 mmHg on repeated measurement),

          7. Systolic blood pressure < 95 mmHg,

          8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,

          9. Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or
             ongoing dialysis,

         10. Clinically relevant bleeding disorder or active bleeding,

         11. Known hypersensitivity to iloprost or any of its excipients.