Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)
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| ClinicalTrials.gov Identifier: NCT00709098 |
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Recruitment Status :
Completed
First Posted : July 3, 2008
Results First Posted : October 29, 2012
Last Update Posted : September 28, 2015
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Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: iloprost | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | September 2008 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Iloprost
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: iloprost power 6
iloprost power 15
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Drug: iloprost
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.
Other Name: Ventavis |
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Experimental: iloprost power 15
iloprost power 15
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Drug: iloprost
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.
Other Name: Ventavis |
Primary Outcome Measures :
- Treatment-emergent 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. ]Number of adverse events
- Treatment-emergent 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. ]Number of serious adverse events
- Adverse Events Leading to Premature Discontinuation of Study Drug [ 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. ]Number of adverse events leading to discontinuation of study treatment
- Patients With Adverse Events Leading to Premature Discontinuation of Study Drug [ 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. ]Number of patients with adverse events leading to discontinuation of study treatment
Other Outcome Measures:
- Average Inhalation Time [ Time Frame: 12 weeks ]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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709098
Locations
Show 34 study locations
Sponsors and Collaborators
Actelion
Investigators
| Study Director: | Laila Rouault, MD | Actelion |
| Responsible Party: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00709098 |
| Other Study ID Numbers: |
AC-063A302 |
| First Posted: | July 3, 2008 Key Record Dates |
| Results First Posted: | October 29, 2012 |
| Last Update Posted: | September 28, 2015 |
| Last Verified: | March 2015 |
Keywords provided by Actelion:
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pulmonary arterial hypertension inhaled treatment inhalation solution iloprost Ventavis |
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary |
Lung Diseases Respiratory Tract Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents |