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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iloprost power 6 | Active Comparator | iloprost power 15 |
|
| iloprost power 15 | Experimental | iloprost power 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iloprost | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | Number of adverse events | 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. |
| Treatment-emergent Serious Adverse Events | Number of serious adverse events | 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. |
| Adverse Events Leading to Premature Discontinuation of Study Drug | Number of adverse events leading to discontinuation of study treatment | 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. |
| Patients With Adverse Events Leading to Premature Discontinuation of Study Drug | Number of patients with adverse events leading to discontinuation of study treatment | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Inhalation Time | 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) | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laila Rouault, MD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | La Jolla | California | 92037 | United States | ||
| UC Davis Medical Center |
Out of the 63 patients who completed the core study of AC-063A301, 49 gave informed consent and enrolled into this extension study.
The double-blind period of the study was conducted at 20 centers in the US and Germany, and the following open-label period of the study was conducted at 17 centers in the US only. First patient, first visit was 4 September 2008 and the last patient, last visit was 17 June 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iloprost Power 6 (Double-blind Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc |
| FG001 | Iloprost Power 15 (Double-blind Period) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period |
|
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|
|
| iloprost | Drug | 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. |
|
|
| Sacramento |
| California |
| 95817 |
| United States |
| Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA | Torrance | California | 90502 | United States |
| Lung Health & Sleep Enhancement Center, LLC | Newark | Delaware | 19713 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Pulmonary & Critical Care of Atlanta | Atlanta | Georgia | 30342 | United States |
| Atlanta Institute for Medical Research | Decatur | Georgia | 30033 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Mercy Hospital | Iowa City | Iowa | 52245 | United States |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | United States |
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7020 | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43221 | United States |
| Legacy Health System | Portland | Oregon | 97210 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Lexington Pulmonary & Critical Care | Lexington | South Carolina | 29072 | United States |
| UT Southwestern Medical Center Heart Lung and Vacular Center | Dallas | Texas | 75390-8550 | United States |
| University of Texas Medical School | Houston | Texas | 77030 | United States |
| Central Utah Clinic, P.C. | American Fork | Utah | 84003 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Sentara Hospitals T/A Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Spokane Respiratory Consultants | Spokane | Washington | 99204 | United States |
| UW Hospital & Clinics | Madison | Wisconsin | 53792 | United States |
| Comprehensive Cardiovascular Care LLP | Milwaukee | Wisconsin | 53215 | United States |
| LHK Universitatsklinikum Graz | Graz | 8036 | Austria |
| Universitatsklinikum Carl-Gustav-Carus | Dresden | D-01307 | Germany |
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc |
| FG002 | Iloprost Power 15 (Open-label Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iloprost Power 6 (Double-blind Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc |
| BG001 | Iloprost Power 15 (Double-blind Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc |
| BG002 | Iloprost Power 15 (Open-label Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Gender | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-emergent Adverse Events | Number of adverse events | Safety population | Posted | Number | adverse events | 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. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Treatment-emergent Serious Adverse Events | Number of serious adverse events | Safety population | Posted | Number | serious adverse events | 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. |
|
| |||||||||||||||||||||||||||||||||
| Primary | Adverse Events Leading to Premature Discontinuation of Study Drug | Number of adverse events leading to discontinuation of study treatment | Safety population | Posted | Number | adverse events | 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. |
| ||||||||||||||||||||||||||||||||||
| Primary | Patients With Adverse Events Leading to Premature Discontinuation of Study Drug | Number of patients with adverse events leading to discontinuation of study treatment | Posted | Number | participants | 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 | Average Inhalation Time | 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) | All treated population | Posted | Mean | Standard Deviation | minutes | 12 weeks |
|
|
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
Treatment-emergent adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iloprost Power 6 (Double-blind Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc | 6 | 25 | 23 | 25 | ||
| EG001 | Iloprost Power 15 (Double-blind Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc | 5 | 24 | 23 | 24 | ||
| EG002 | Iloprost Power 15 (Open-label Period) | The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc | 8 | 32 | 25 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| DIVERTICULUM | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| SUDDEN CARDIAC DEATH | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NO THERAPEUTIC RESPONSE | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laila Rouault, MD/International Clinical Leader | Actelion Pharmaceuticals Ltd | + 41 61 565 8128 |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Death |
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| Lost to Follow-up |
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| Male |
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| Germany |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Participants |
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