Clinical trial NCT00741819: Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
Official title: An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
PAH
treprostinil sodium
inhalation
ventavis
iloprost
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 75 years of age
* PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired \>/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
* Baseline six-minute walk distance (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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: up to 24 months
Secondary outcomes:
measure: Six-minute Walk Distance (6MWD)
timeFrame: Baseline and 12 weeks
measure: Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
timeFrame: Baseline and 12 weeks
measure: Treatment Satisfaction Questionnaire of Medication (TSQM)
timeFrame: Baseline and 12 weeks
measure: Patient Impression of Change
timeFrame: Baseline and 12 weeks
measure: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)
timeFrame: Baseline and Week 12
measure: World Health Organization (WHO) Functional Class
timeFrame: Baseline and 12 Weeks
measure: Drug Administration Activities Questionnaire
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center - North Shore
state: New York
city: New York City
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York City
country: United States
facility: Cornell University Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Rochester
country: United States
facility: Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: