Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension - Full Text View

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00709098

Purpose

Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in NYHA class II to IV 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 PAH. After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: iloprost	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Treatment-emergent adverse events [ Time Frame: From first inhalation of study drug to day before end of 12-week treatment period ] [ Designated as safety issue: Yes ]
Treatment-emergent serious adverse events [ Time Frame: From first inhalation of study drug to the day before the end of 12-week treatment period ] [ Designated as safety issue: Yes ]
Adverse events leading to premature discontinuation of study drug [ Time Frame: From the first inhalation of study drug to discontinuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Treatment-emergent adverse events and serious adverse events leading to study drug discontinuation [ Time Frame: Open label period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	63
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental iloprost power 15	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.
2: Active Comparator iloprost power 6	Drug: iloprost Iloprost 5 mcg delivered by I-neb(R)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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709098

Show 33 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Laila Rouault, MD

Actelion

More Information

No publications provided

Responsible Party:	Actelion ( Laila Rouault, MD )
Study ID Numbers:	AC-063A302
Study First Received:	July 1, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00709098 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Ventavis
iloprost
inhaled treatment
inhalation solution
pulmonary arterial hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Iloprost
Respiratory Tract Diseases

Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 09, 2009