Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Information source: Actelion
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: iloprost (Drug); iloprost (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Actelion Official(s) and/or principal investigator(s):
Laila Rouault, MD, Study Director, Affiliation: Actelion
Summary
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
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Primary outcome: Treatment-emergent adverse eventsTreatment-emergent serious adverse events Adverse events leading to premature discontinuation of study drug
Secondary outcome: Treatment-emergent adverse events and serious adverse events leading to study drug discontinuation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18 or greater,
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 serum pregnancy test and must use
an adequate method of contraception during the study and for 28 days after
discontinuation of the study drug,
4. Patients able to provide written consent.
Exclusion Criteria:
1. Patients with any major violation of protocol AC-063A301,
2. Patients who are pregnant or breast-feeding,
3. Patients with clinically relevant bleeding disorder or active bleeding,
4. Patients with hypersensitivity to iloprost or any of the excipients will be excluded.
Locations and Contacts
UCSD Medical Center, La Jolla, California 92037, United States; Not yet recruiting
Diane Conger, Phone: 858-657-7121, Email: dconger@ucsd.edu
Victor Test, MD, Principal Investigator
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Not yet recruiting
Page Scovel, RN, BSN, CCRC, Phone: 319-384-8005, Email: page-scovel@uiowa.edu
James L. Carroll, MD, Principal Investigator
LSU Health Sciences Center, New Orleans, Louisiana 70112, United States; Not yet recruiting
Paula O. Lauto, RN, BSN, CCRN, Phone: 504-568-3451, Email: plauto@lsuhsc.edu
Bennett deBoisblanc, MD, Principal Investigator
University of Maryland Medical Center, Baltimore, Maryland 21201, United States; Not yet recruiting
Faith E. Pa'Ahana-Janowick, RN, BSN, Phone: 410-706-8247, Email: fjanowic@medicine.umaryland.edu
Myung H. Park, MD, Principal Investigator
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Not yet recruiting
Traci Nelson, MS, CRC, Phone: 402-559-7585, Email: trnelson@unmc.edu
Austin Thompson, MD, Principal Investigator
The Ohio State University Medical Center, Columbus, Ohio 43221, United States; Not yet recruiting
Sharon Cheung, BS, CCRC, Phone: 614-366-2258, Email: sharon.cheung@osumc.edu
Namita Sood, MD, Principal Investigator
The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States; Recruiting
Roxanne Robertson, RN, Phone: 513-585-1777, Email: robertson.lctc@fuse.net
Peter J. Engle, MD, Principal Investigator
Rhode Island Hospital, Providence, Rhode Island 02903, United States; Not yet recruiting
Barbara Smithson, Phone: 401-444-9097, Email: bsmithson@lifespan.org
James R. Klinger, MD, Principal Investigator
Scott & White Memorial Hospital, Temple, Texas 76508, United States; Not yet recruiting
Lydia Clipper, Phone: 254-724-8193, Email: lclipper@swmail.sw.org
Christopher D. Spradley, MD, Principal Investigator
Intermountain Medical Center, Murray, Utah 84157, United States; Not yet recruiting
Deedre Boekweg, BSN, RN, Phone: 801-507-4698, Email: deedre.boekweg@imail.org
C. Gregory Elliott, MD, Principal Investigator
Comprehensive Cardiovascular Care LLP, Milwaukee, Wisconsin 53215, United States; Not yet recruiting
Don Lobacz, Phone: 414-649-3438, Email: dlobacz@hrtcare.com
Kianne L. Zwicke, MD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: February 2009
Last updated: July 22, 2008
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