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Ventavis® Registry Protocol (RESPIRE)

This study is currently recruiting participants.
Verified April 2012 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00902603
First received: May 13, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  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:

Drug Information available for: Iloprost
U.S. FDA Resources

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 ]

Estimated Enrollment: 300
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902603

Contacts
Contact: Sandy Petersen sandy.petersen@actelion.com

  Show 31 Study Locations
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: April 25, 2012
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 May 16, 2013