Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in PAH Subjects - Full Text View

Sponsored by:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00741819

Purpose

This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).

Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled Treprostinil Sodium	Phase IV

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Iloprost U 62840

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open Label, Multi-Center Study Evaluating the Safety of Long-Term Inhaled Treprostinil Sodium Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Safety evaluated by combined assessments of adverse events, disease-related events, and clinical laboratory parameters [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Questionnaires (CAMPHOR quality of life, treatment satisfaction for medication, patient impression of change, drug administration activities) 6MW distance, borg dyspnea score, WHO functional class of PH, PAH signs & symptoms, n-terminal pro-BNP [ Time Frame: 12 weeks to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Treprostinil sodium, 0.6 mg/mL solution for inhalation.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 18 and 70 years of age
PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
Baseline 6MWD >/= 250 meters
Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

Nursing or pregnant
Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
Use of investigational drug within 30 days of Baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741819

Locations

United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCSD Medical Center
La Jolla, California, United States, 82037
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Long Island Jewish Medical Center - North Shore
New Hyde Park, New York, United States, 11040
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

United Therapeutics

More Information

Responsible Party:	United Therapeutics Corp. ( C. Shane McSwain, MHSc / Associate Manager, Clinical Affairs )
Study ID Numbers:	RIN-PH-401
Study First Received:	August 23, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741819
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

pulmonary arterial hypertension
PAH
treprostinil sodium

inhalation
ventavis
iloprost

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Iloprost
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Treprostinil
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009