Iloprost Power 15 in Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00709956

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 will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with PAH.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: iloprost power 15 ( Ventavis(R)) Drug: placebo	Phase III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

Drug Information available for: Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension

Further study details as provided by Actelion:

Primary Outcome Measures:

6-minute-walk distance after a single dose of iloprost power 15 or placebo [ Time Frame: Day 2 or 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Borg dyspnea score after a single dose of iloprost power 15 or placebo [ Time Frame: Day 2 or 3 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental iloprost power 15	Drug: iloprost power 15 ( Ventavis(R)) Single dose of iloprost 5 mcg using I-neb(R)AAD(R)System power setting 15 disc
2: Placebo Comparator placebo	Drug: placebo Single dose of matching placebo using I-neb(R)AAD(R)System power setting 15 disc

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 or greater,
Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV,
Patients with documented Pulmonary arterial hypertension confirmed by right heart catheterization within 3 years,
Six minute walk distance of between 150 m and 450 meters,
Patients on a stable dose regimen of either bosentan or sildenafil monotherapy for at least 12 weeks,
Patients able to provide written consent.

Exclusion Criteria:

Patients with pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
Patients with moderate to severe obstructive lung disease: FEV1/FVC < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
Patients with moderate to severe restrictive lung disease: TLC < 60% of predicted value,
Patients who are pregnant or breast-feeding,
Patients with moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
Patients with chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
Patients with clinically relevant bleeding disorder or active bleeding
Patients with < 95 mmHg Systolic blood pressure,
Patients unable to use the inhalation device will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709956

Show 21 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Laila Rouault, MD

Actelion

More Information

Responsible Party:	Actelion ( Laila Rouault, MD )
Study ID Numbers:	AC-063A301
Study First Received:	July 1, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00709956
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Ventavis
iloprost
pulmonary arterial hypertension
inhaled treatment

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Iloprost
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009