NCT00902603

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

May 13, 2009

Last Update Submit

January 31, 2025

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertensionVentavis®iloprost

Outcome Measures

Primary Outcomes (1)

  • Adherence with instructions for use of Ventavis®

    2 years

Secondary Outcomes (1)

  • Persistence of use of Ventavis®

    2 years

Study Arms (1)

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)

Interventions

Commercial Ventavis® (iloprost)DRUG

Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)

1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • Have a current diagnosis of WHO Group I PAH
  • 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
  • Age \> or = 18 years old at the time of enrollment

You may not qualify if:

  • Are not currently on commercial Ventavis®
  • Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 3, 2025

Record last verified: 2025-01