Phase 3 N=49 Randomized Quadruple-blind Treatment

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00709098 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

Oct 2012

Primary outcome: Primary: Treatment-emergent Adverse Events — 148; 139; 126 adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: iloprost (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Actelion
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment-emergent Adverse Events	148; 139; 126	—
PRIMARY Treatment-emergent Serious Adverse Events	11; 11; 10	—
PRIMARY Adverse Events Leading to Premature Discontinuation of Study Drug	3; 10; 7	—
PRIMARY Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	2; 6; 7	—

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.

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) 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
Systolic blood pressure 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.

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Data sourced from ClinicalTrials.gov (NCT00709098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.