Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

NCT00709098 | Completed Phase 3 Results

• 1 other identifier: AC-063A302
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 34

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension; inhaled treatment; inhalation solution; iloprost; Ventavis

Outcome Measures

Primary Outcomes (4)

• Treatment-emergent Adverse Events

  Number of 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.

• Treatment-emergent Serious Adverse Events

  Number of 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.

• Adverse Events Leading to Premature Discontinuation of Study Drug

  Number of adverse events leading to discontinuation of study treatment

  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.

• Patients With Adverse Events Leading to Premature Discontinuation of Study Drug

  Number of patients with adverse events leading to discontinuation of study treatment

  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.

Other Outcomes (1)

• Average Inhalation Time

  12 weeks

Study Arms (2)

iloprost power 6

ACTIVE COMPARATOR

iloprost power 15

Drug: iloprost

iloprost power 15

EXPERIMENTAL

iloprost power 15

Drug: iloprost

Interventions

iloprost DRUG

Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (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.

Also known as: Ventavis

iloprost power 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Known hypersensitivity to iloprost or any of its excipients.

Sponsors & Collaborators

• Actelion: lead

Study Sites (34)

UCSD Medical Center

La Jolla, California, 92037, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA

Torrance, California, 90502, United States

Location

Lung Health & Sleep Enhancement Center, LLC

Newark, Delaware, 19713, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Pulmonary & Critical Care of Atlanta

Atlanta, Georgia, 30342, United States

Location

Atlanta Institute for Medical Research

Decatur, Georgia, 30033, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Hospital

Iowa City, Iowa, 52245, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

University of North Carolina

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

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43221, United States

Location

Legacy Health System

Portland, Oregon, 97210, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Lexington Pulmonary & Critical Care

Lexington, South Carolina, 29072, United States

Location

UT Southwestern Medical Center Heart Lung and Vacular Center

Dallas, Texas, 75390-8550, United States

Location

University of Texas Medical School

Houston, Texas, 77030, United States

Location

Central Utah Clinic, P.C.

American Fork, Utah, 84003, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Hospitals T/A Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Spokane Respiratory Consultants

Spokane, Washington, 99204, United States

Location

UW Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Comprehensive Cardiovascular Care LLP

Milwaukee, Wisconsin, 53215, United States

Location

LHK Universitatsklinikum Graz

Graz, 8036, Austria

Location

Universitatsklinikum Carl-Gustav-Carus

Dresden, D-01307, Germany

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Laila Rouault, MD/International Clinical Leader
• Organization: Actelion Pharmaceuticals Ltd

+ 41 61 565 8128

Study Officials

• Laila Rouault, MD

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 28, 2015
• Results First Posted: October 29, 2012

Record last verified: 2015-03

Locations

AU (1); US (32); DE (1)