Efficacy of Ventavis Used in Real-life Setting. (SPHERA)

October 16, 2017 updated by: Bayer

The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Many Locations, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Retrospective documentation is not allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug (incl. Placebo)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of the exercise capacity as measured by 6-minutes walking distance
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of depression score over time
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Changes of pulmonary haemodynamics
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Changes of serum level of natriuretic peptide B
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Changes of Quality of Life score
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Changes in cardiac echo parameters
Time Frame: 3, 6, 9 and 12 months vs. baseline
3, 6, 9 and 12 months vs. baseline
Number of patients with treatment-emergent adverse events
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2010

Primary Completion (Actual)

April 28, 2016

Study Completion (Actual)

September 22, 2016

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Arterial Hypertension

Clinical Trials on Inhaled iloprost (Ventavis, BAYQ6256)

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