Clinical trial NCT00709098: Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
inhaled treatment
inhalation solution
iloprost
Ventavis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Treatment-emergent Adverse Events
timeFrame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.
measure: Treatment-emergent Serious Adverse Events
timeFrame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.
measure: Adverse Events Leading to Premature Discontinuation of Study Drug
timeFrame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.
measure: Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
timeFrame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.
Secondary outcomes:
Other outcomes:
measure: Average Inhalation Time
timeFrame: 12 weeks
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Torrance
country: United States
facility: Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
state: California
city: Newark
country: United States
facility: Lung Health & Sleep Enhancement Center, LLC
state: Delaware
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Pulmonary & Critical Care of Atlanta
state: Georgia
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Iowa City
country: United States
facility: Mercy Hospital
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Legacy Health System
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Lexington
country: United States
facility: Lexington Pulmonary & Critical Care
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center Heart Lung and Vacular Center
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: American Fork
country: United States
facility: Central Utah Clinic, P.C.
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospitals T/A Sentara Cardiovascular Research Institute
state: Virginia
city: Spokane
country: United States
facility: Spokane Respiratory Consultants
state: Washington
city: Madison
country: United States
facility: UW Hospital & Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Comprehensive Cardiovascular Care LLP
state: Wisconsin
city: Graz
country: Austria
facility: LHK Universitatsklinikum Graz
city: Dresden
country: Germany
facility: Universitatsklinikum Carl-Gustav-Carus
Study officials:
affiliation: Actelion
name: Laila Rouault, MD
role: STUDY_DIRECTOR
References: