NCT01355380

Brief Summary

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis. Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 5, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2016

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

5.7 years

First QC Date

May 17, 2011

Last Update Submit

October 16, 2017

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertensionInhaled iloprostQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes of the exercise capacity as measured by 6-minutes walking distance

    3, 6, 9 and 12 months vs. baseline

Secondary Outcomes (7)

  • Changes of depression score over time

    3, 6, 9 and 12 months vs. baseline

  • Changes of functional capacity as measured by WHO classification system

    3, 6, 9 and 12 months vs. baseline

  • Changes of pulmonary haemodynamics

    3, 6, 9 and 12 months vs. baseline

  • Changes of serum level of natriuretic peptide B

    3, 6, 9 and 12 months vs. baseline

  • Changes of Quality of Life score

    3, 6, 9 and 12 months vs. baseline

  • +2 more secondary outcomes

Study Arms (1)

Group 1

Drug (incl. Placebo)

Drug: Inhaled iloprost (Ventavis, BAYQ6256)

Interventions

Inhaled iloprost (Ventavis, BAYQ6256)DRUG

Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.

You may qualify if:

  • Pulmonary arterial hypertension in WHO functional class III or IV
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

You may not qualify if:

  • Retrospective documentation is not allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

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 Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 18, 2011

Study Start

August 5, 2010

Primary Completion

April 28, 2016

Study Completion

September 22, 2016

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

PL(1)