Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Completed · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT00709098

Run by

Actelion

People needed

49

Starts

2008-09-01

Expected to finish

2010-06-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD Medical Center — La Jolla, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA — Torrance, California, United States
• Lung Health & Sleep Enhancement Center, LLC — Newark, Delaware, United States
• University of Florida — Gainesville, Florida, United States
• Pulmonary & Critical Care of Atlanta — Atlanta, Georgia, United States
• Atlanta Institute for Medical Research — Decatur, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Mercy Hospital — Iowa City, Iowa, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• LSU Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Legacy Health System — Portland, Oregon, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Lexington Pulmonary & Critical Care — Lexington, South Carolina, United States
• UT Southwestern Medical Center Heart Lung and Vacular Center — Dallas, Texas, United States
• University of Texas Medical School — Houston, Texas, United States

Full record on ClinicalTrials.gov

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