Ventavis® Registry Protocol (RESPIRE)

This study has been terminated.
(low enrollment rate and difficulty in recruiting eligible patients in adequate time)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00902603
First received: May 13, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.


Condition Intervention
Pulmonary Arterial Hypertension
Drug: Commercial Ventavis® (iloprost)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Adherence with instructions for use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence of use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months.
Drug: Commercial Ventavis® (iloprost)
Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

  1. Have a current diagnosis of WHO Group I PAH
  2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
  3. Age > or = 18 years old at the time of enrollment

Exclusion Criteria:

  1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
  2. Are not currently on commercial Ventavis®
  3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902603

  Hide Study Locations
Locations
United States, California
UCSF Fresno
Fresno, California, United States, 93721
UCSD Medical Center
La Jolla, California, United States, 92037
UCLA
Los Angeles, California, United States, 90095
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
United States, Colorado
Western States Clinical Research
Wheatridge, Colorado, United States, 80033
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Central Florida Pulmonary Group
Orlando, Florida, United States, 32803
Orlando Heart Center
Orlando, Florida, United States, 32806
Cleveland Cliic Florida
Weston, Florida, United States, 33331
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, Nebraska
Nebraska Pulmonary Specialties
Lincoln, Nebraska, United States, 68506
United States, Nevada
Sierra Nevada Cardiology Associates
Reno, Nevada, United States, 89502
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Kaleida Health/Buffalo General Hospital
Buffalo, New York, United States, 14203
Winthrop University Hospital
Mineola, New York, United States, 11501
North Shore University - LIJ Medical Center
New Hyde Park, New York, United States, 10029
Beth Israel Medical Center
New York, New York, United States, 10003
Pulmonary Health Physicians
Syracuse, New York, United States, 13210
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylore College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Central Utah Clinic
Provo, Utah, United States, 84057
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00902603     History of Changes
Other Study ID Numbers: AC-063A501
Study First Received: May 13, 2009
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Actelion:
pulmonary arterial hypertension
Ventavis®
iloprost

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014