Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH) - Full Text View

Purpose

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Condition	Intervention	Phase
Pulmonary Arterial Hypertension Ayerza Syndrome Pulmonary Hypertension	Drug: Iloprost or placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

Drug Information available for: Iloprost Bosentan

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Further study details as provided by Actelion:


Estimated Enrollment:	60
Study Start Date:	June 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Eligibility


Ages Eligible for Study:	12 Years to 75 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
NYHA Functional Class III or IV
On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
Age 12-75 years, of either gender
Six minute walk distance 100-425 meters at Baseline

Exclusion Criteria:

Any new long-term treatment for PAH added within the last 4 weeks
Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086463

Locations


United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCSD Medical Center
La Jolla, California, United States, 92037
Stanford University Medical Center
Palo Alto, California, United States, 94305
UCSF Medical Center
San Francisco, California, United States, 94143
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
University of Colorado HSC
Denver, Colorado, United States, 80262
United States, Illinois
Rush Heart Institute, Center for Pulmonary Heart Disease
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55095
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143

Sponsors and Collaborators

Actelion

Investigators


Study Director:	Henry Hsu, M.D.	CoTherix

More Information

Publications:

Olschewski H, Simonneau G, Galiè N, Higenbottam T, Naeije R, Rubin LJ, Nikkho S, Speich R, Hoeper MM, Behr J, Winkler J, Sitbon O, Popov W, Ghofrani HA, Manes A, Kiely DG, Ewert R, Meyer A, Corris PA, Delcroix M, Gomez-Sanchez M, Siedentop H, Seeger W; Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002 Aug 1;347(5):322-9.


ClinicalTrials.gov Identifier:	NCT00086463 History of Changes
Other Study ID Numbers:	STEP STUDY STEP Pulmonary Hypertension Pulmonary Artery Cotherix
Study First Received:	July 1, 2004
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:


STEP PAH iloprost inhalation prostacyclin

Additional relevant MeSH terms:


Hypertension Hypertension, Pulmonary Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases	Bosentan Iloprost Antihypertensive Agents Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Vasodilator Agents

ClinicalTrials.gov processed this record on September 23, 2016