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Iloprost Power 15 in Pulmonary Arterial Hypertension

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: iloprost (5 µg) (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Laila Rouault, MD, Study Director, Affiliation: Actelion

Summary

Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan 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 pulmonary arterial hypertension (PAH).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 6-minute-walk Distance (6MWD)

Secondary outcome: Borg Dyspnea Score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent prior to initiation of any study mandated procedure,

- Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or

pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.

- 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) < 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,

- For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or

sildenafil, according to product label,

- Known hypersensitivity to iloprost or any of its excipients.

Locations and Contacts

LKH Universitatsklinikum Graz, Graz 8036, Austria

Universitatsklinikum Carl-Gustav-Carus, Dresden D-01307, Germany

UCSD Medical Center, La Jolla, California 92037, United States

UC Davis Medical Center, Sacramento, California 95817, United States

Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA, Torrance, California 90502, United States

Lung Health & Sleep Enhancement Center, LLC, Newark, Delaware 19713, United States

University of Florida, Gainesville, Florida 32610, United States

Pulmonary & Critical Care of Atlanta, Atlanta, Georgia 30342, United States

Atlanta Institute for Medical Research, Decatur, Georgia 30033, United States

Mercy Hospital, Iowa City, Iowa 52245, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Kentuckiana Pulmonary Associates, Louisville, Kentucky 40202, United States

LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

University of Maryland Medical Center, Baltimore, Maryland 21201, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

Winthrop University Hospital, Mineola, New York 11501, United States

University of North Carolina, Chapel Hill, North Carolina 27599-7020, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States

The Ohio State University Medical Center, Columbus, Ohio 43221, United States

Legacy Health System, Portland, Oregon 97210, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Lexington Pulmonary & Critical Care, Lexington, South Carolina 29072, United States

UT Southwestern Medical Center Heart Lung and Vascular Center, Dallas, Texas 75390-8550, United States

University of Texas Medical School, Houston, Texas 77030, United States

Central Utah Clinic, P.C., American Fork, Utah 84003, United States

Intermountain Medical Center, Murray, Utah 84157, United States

University of Virginia, Charlottesville, Virginia VA, United States

Sentara Hospitals T/A Sentara Cardiovascular Research Institute, Norfolk, Virginia 23507, United States

Spokane Respiratory Consultants, Spokane, Washington 99204, United States

UW Hospital & Clinics, Madison, Wisconsin 53792, United States

Comprehensive Cardiovascular Care LLP, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: July 2008
Last updated: September 27, 2012

Page last updated: August 23, 2015

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