Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
NCT ID: NCT00709098
Last Updated: 2015-09-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2008-09-30
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Iloprost Power 15 in Pulmonary Arterial Hypertension
NCT00709956
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
NCT00185315
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
NCT00723554
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
NCT01894035
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
NCT00120380
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iloprost power 6
iloprost power 15
iloprost
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 power 15
iloprost power 15
iloprost
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iloprost
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
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Actelion
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laila Rouault, MD
Role: STUDY_DIRECTOR
Actelion
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Intermountain Medical Center
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
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
Central Utah Clinic, P.C.
American Fork, Utah, United States
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Spokane Respiratory Consultants
Spokane, Washington, United States
UW Hospital & Clinics
Madison, Wisconsin, United States
Comprehensive Cardiovascular Care LLP
Milwaukee, Wisconsin, United States
LHK Universitatsklinikum Graz
Graz, , Austria
Universitatsklinikum Carl-Gustav-Carus
Dresden, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AC-063A302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.