Status:
COMPLETED
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- Signed informed consent prior to initiation of any study mandated procedure,
- Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
- 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
- Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- 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,
- 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,
- Moderate to severe restrictive lung disease: total lung capacity (TLC) \< 60% of predicted value,
- Pregnant or breast-feeding women,
- Systemic hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg on repeated measurement),
- Systolic blood pressure \< 95 mmHg,
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- Chronic renal insufficiency defined by serum creatinine \> 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
- Clinically relevant bleeding disorder or active bleeding,
- Known hypersensitivity to iloprost or any of its excipients.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00709098
Start Date
September 1 2008
End Date
June 1 2010
Last Update
September 28 2015
Active Locations (34)
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1
UCSD Medical Center
La Jolla, California, United States, 92037
2
UC Davis Medical Center
Sacramento, California, United States, 95817
3
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
Torrance, California, United States, 90502
4
Lung Health & Sleep Enhancement Center, LLC
Newark, Delaware, United States, 19713