Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Phase 3

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: iloprost

• Registration Number: NCT00709098
• Lead Sponsor: Actelion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Study Start: 2008-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2012-09-27
• Results First Submitted QC: 2012-09-27
• Results First Posted: 2012-10-29
• Status Verified: 2015-03
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iloprost power 15	iloprost	iloprost power 15
iloprost power 6	iloprost	iloprost power 15

Primary Outcome Measures

Name	Time	Method
Treatment-emergent 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.	Number of adverse events
Adverse Events Leading to Premature Discontinuation of Study Drug	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
Treatment-emergent 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.	Number of serious adverse events
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	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

Trial Locations

Locations (34)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA; 🇺🇸 Torrance, California, United States

Lung Health & Sleep Enhancement Center, LLC; 🇺🇸 Newark, Delaware, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Pulmonary & Critical Care of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Atlanta Institute for Medical Research; 🇺🇸 Decatur, Georgia, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Mercy Hospital; 🇺🇸 Iowa City, Iowa, United States

Kentuckiana Pulmonary Associates; 🇺🇸 Louisville, Kentucky, United States

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