Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension - Full Text View

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00709098

Purpose

Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in NYHA class II to IV 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 PAH. After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: iloprost	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Official Title:	A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Treatment-emergent adverse events [ Time Frame: From first inhalation of study drug to day before end of 12-week treatment period ] [ Designated as safety issue: Yes ]
Treatment-emergent serious adverse events [ Time Frame: From first inhalation of study drug to the day before the end of 12-week treatment period ] [ Designated as safety issue: Yes ]
Adverse events leading to premature discontinuation of study drug [ Time Frame: From the first inhalation of study drug to discontinuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Treatment-emergent adverse events and serious adverse events leading to study drug discontinuation [ Time Frame: Open label period ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental iloprost power 15	Drug: 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.
2: Active Comparator iloprost power 6	Drug: iloprost Iloprost 5 mcg delivered by I-neb(R)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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709098

Hide Study Locations

Locations

United States, California
UCSD Medical Center
La Jolla, California, United States, 92037
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
Torrance, California, United States, 90502
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Delaware
Lung Health & Sleep Enhancement Center, LLC
Newark, Delaware, United States, 19713
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, United States, 30342
Atlanta Institute for Medical Research
Decatur, Georgia, United States, 30033
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Hospital
Iowa City, Iowa, United States, 52245
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7020
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
United States, Oregon
Legacy Health System
Portland, Oregon, United States, 97210
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Lexington Pulmonary & Critical Care
Lexington, South Carolina, United States, 29072
United States, Texas
UT Southwestern Medical Center Heart Lung and Vacular Center
Dallas, Texas, United States, 75390-8550
University of Texas Medical School
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Central Utah Clinic, P.C.
American Fork, Utah, United States, 84003
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
United States, Washington
Spokane Respiratory Consultants
Spokane, Washington, United States, 99204
United States, Wisconsin
Comprehensive Cardiovascular Care LLP
Milwaukee, Wisconsin, United States, 53215
UW Hospital & Clinics
Madison, Wisconsin, United States, 53792
Germany
Universitatsklinikum Carl-Gustav-Carus
Dresden, Germany, D-01307

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Laila Rouault, MD

Actelion

More Information

No publications provided

Responsible Party:	Actelion ( Laila Rouault, MD )
Study ID Numbers:	AC-063A302
Study First Received:	July 1, 2008
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00709098 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Ventavis
iloprost
inhaled treatment
inhalation solution
pulmonary arterial hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Iloprost
Respiratory Tract Diseases

Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009