Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00709098 |
Date of registration:
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01/07/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
PROWESS 15 Ext |
Scientific title:
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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 |
Date of first enrolment:
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September 2008 |
Target sample size:
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49 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00709098 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Germany
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United States
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Contacts
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Name:
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Laila Rouault, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Actelion |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: iloprost
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Primary Outcome(s)
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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.]
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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.]
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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.]
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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.]
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Secondary ID(s)
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AC-063A302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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