Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
- Registration Number
- NCT00709098
- Lead Sponsor
- Actelion
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iloprost power 15 iloprost iloprost power 15 iloprost power 6 iloprost iloprost power 15
- Primary Outcome Measures
Name Time Method Treatment-emergent Adverse Events Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. Number of adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. Number of adverse events leading to discontinuation of study treatment
Treatment-emergent Serious Adverse Events Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. Number of serious adverse events
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. Number of patients with adverse events leading to discontinuation of study treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
LHK Universitatsklinikum Graz
🇦🇹Graz, Austria
UCSD Medical Center
🇺🇸La Jolla, California, United States
Universitatsklinikum Carl-Gustav-Carus
🇩🇪Dresden, Germany
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Pulmonary & Critical Care of Atlanta
🇺🇸Atlanta, Georgia, United States
Atlanta Institute for Medical Research
🇺🇸Decatur, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center Heart Lung and Vacular Center
🇺🇸Dallas, Texas, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Legacy Health System
🇺🇸Portland, Oregon, United States
Comprehensive Cardiovascular Care LLP
🇺🇸Milwaukee, Wisconsin, United States
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
🇺🇸Torrance, California, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
University of Texas Medical School
🇺🇸Houston, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Central Utah Clinic, P.C.
🇺🇸American Fork, Utah, United States
Spokane Respiratory Consultants
🇺🇸Spokane, Washington, United States
UW Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
Lung Health & Sleep Enhancement Center, LLC
🇺🇸Newark, Delaware, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Mercy Hospital
🇺🇸Iowa City, Iowa, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Lexington Pulmonary & Critical Care
🇺🇸Lexington, South Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States