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Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: iloprost (Drug); iloprost (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Laila Rouault, MD, Study Director, Affiliation: Actelion

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Treatment-emergent Adverse Events

Treatment-emergent Serious Adverse Events

Adverse Events Leading to Premature Discontinuation of Study Drug

Patients With Adverse Events Leading to Premature Discontinuation of Study Drug

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed informed consent prior to initiation of any study mandated procedure, 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. Exclusion Criteria: 1. Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria, 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.

Locations and Contacts

LHK Universitatsklinikum Graz, Graz 8036, Austria

Universitatsklinikum Carl-Gustav-Carus, Dresden D-01307, Germany

UCSD Medical Center, La Jolla, California 92037, United States

UC Davis Medical Center, Sacramento, California 95817, United States

Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA, Torrance, California 90502, United States

Lung Health & Sleep Enhancement Center, LLC, Newark, Delaware 19713, United States

University of Florida, Gainesville, Florida 32610, United States

Pulmonary & Critical Care of Atlanta, Atlanta, Georgia 30342, United States

Atlanta Institute for Medical Research, Decatur, Georgia 30033, United States

Mercy Hospital, Iowa City, Iowa 52245, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Kentuckiana Pulmonary Associates, Louisville, Kentucky 40202, United States

LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

University of Maryland Medical Center, Baltimore, Maryland 21201, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

Winthrop University Hospital, Mineola, New York 11501, United States

University of North Carolina, Chapel Hill, North Carolina 27599-7020, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States

The Ohio State University Medical Center, Columbus, Ohio 43221, United States

Legacy Health System, Portland, Oregon 97210, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Lexington Pulmonary & Critical Care, Lexington, South Carolina 29072, United States

UT Southwestern Medical Center Heart Lung and Vacular Center, Dallas, Texas 75390-8550, United States

University of Texas Medical School, Houston, Texas 77030, United States

Central Utah Clinic, P.C., American Fork, Utah 84003, United States

Intermountain Medical Center, Murray, Utah 84157, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Sentara Hospitals T/A Sentara Cardiovascular Research Institute, Norfolk, Virginia 23507, United States

Spokane Respiratory Consultants, Spokane, Washington 99204, United States

UW Hospital & Clinics, Madison, Wisconsin 53792, United States

Comprehensive Cardiovascular Care LLP, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: September 2008
Last updated: November 29, 2012

Page last updated: August 23, 2015

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