Back to resultsSafety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
iloprost
iloprost
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, inhaled treatment, inhalation solution, iloprost, Ventavis
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent prior to initiation of any study mandated procedure,
- Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
- 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:
- Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- 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,
- 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,
- Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
- Pregnant or breast-feeding women,
- Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
- Systolic blood pressure < 95 mmHg,
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
- Clinically relevant bleeding disorder or active bleeding,
- Known hypersensitivity to iloprost or any of its excipients.
Sites / Locations
- UCSD Medical Center
- UC Davis Medical Center
- Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
- Lung Health & Sleep Enhancement Center, LLC
- University of Florida
- Pulmonary & Critical Care of Atlanta
- Atlanta Institute for Medical Research
- University of Iowa Hospitals and Clinics
- Mercy Hospital
- Kentuckiana Pulmonary Associates
- LSU Health Sciences Center
- University of Maryland Medical Center
- University of Nebraska Medical Center
- Newark Beth Israel Medical Center
- Winthrop University Hospital
- University of North Carolina
- The Lindner Clinical Trial Center
- The Ohio State University Medical Center
- Legacy Health System
- Temple University Hospital
- Allegheny General Hospital
- Rhode Island Hospital
- Lexington Pulmonary & Critical Care
- UT Southwestern Medical Center Heart Lung and Vacular Center
- University of Texas Medical School
- Central Utah Clinic, P.C.
- Intermountain Medical Center
- University of Virginia
- Sentara Hospitals T/A Sentara Cardiovascular Research Institute
- Spokane Respiratory Consultants
- UW Hospital & Clinics
- Comprehensive Cardiovascular Care LLP
- LHK Universitatsklinikum Graz
- Universitatsklinikum Carl-Gustav-Carus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
iloprost power 6
iloprost power 15
Arm Description
iloprost power 15
iloprost power 15
Outcomes
Primary Outcome Measures
Treatment-emergent Adverse Events
Number of adverse events
Treatment-emergent Serious Adverse Events
Number of serious adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug
Number of adverse events leading to discontinuation of study treatment
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
Number of patients with adverse events leading to discontinuation of study treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00709098
Brief Title
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Acronym
PROWESS 15 Ext
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, inhaled treatment, inhalation solution, iloprost, Ventavis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iloprost power 6
Arm Type
Active Comparator
Arm Description
iloprost power 15
Arm Title
iloprost power 15
Arm Type
Experimental
Arm Description
iloprost power 15
Intervention Type
Drug
Intervention Name(s)
iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
Intervention Type
Drug
Intervention Name(s)
iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events
Description
Number of adverse events
Time Frame
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.
Title
Treatment-emergent Serious Adverse Events
Description
Number of serious adverse events
Time Frame
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.
Title
Adverse Events Leading to Premature Discontinuation of Study Drug
Description
Number of adverse events leading to discontinuation of study treatment
Time Frame
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.
Title
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
Description
Number of patients with adverse events leading to discontinuation of study treatment
Time Frame
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.
Other Pre-specified Outcome Measures:
Title
Average Inhalation Time
Description
Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent prior to initiation of any study mandated procedure,
Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
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:
Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
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,
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,
Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
Pregnant or breast-feeding women,
Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
Systolic blood pressure < 95 mmHg,
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
Clinically relevant bleeding disorder or active bleeding,
Known hypersensitivity to iloprost or any of its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laila Rouault, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Lung Health & Sleep Enhancement Center, LLC
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pulmonary & Critical Care of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Institute for Medical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mercy Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7020
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Lexington Pulmonary & Critical Care
City
Lexington
State/Province
South Carolina
ZIP/Postal Code
29072
Country
United States
Facility Name
UT Southwestern Medical Center Heart Lung and Vacular Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8550
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Utah Clinic, P.C.
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Spokane Respiratory Consultants
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
UW Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Comprehensive Cardiovascular Care LLP
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
LHK Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitatsklinikum Carl-Gustav-Carus
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
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