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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01355380
First received: May 17, 2011
Last updated: November 24, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Inhaled iloprost (Ventavis, BAYQ6256)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Changes of the exercise capacity as measured by 6-minutes walking distance [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of depression score over time [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of functional capacity as measured by WHO classification system [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of pulmonary haemodynamics [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of serum level of natriuretic peptide B [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of Quality of Life score [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: August 2010
Study Completion Date: September 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Drug (incl. Placebo)
Drug: Inhaled iloprost (Ventavis, BAYQ6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Criteria

Inclusion Criteria:

  • Pulmonary arterial hypertension
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

  • Retrospective documentation is not allowed
  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: NCT01355380

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01355380     History of Changes
Other Study ID Numbers: 15308  VE1010PL 
Study First Received: May 17, 2011
Last Updated: November 24, 2016
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Pulmonary arterial hypertension
Inhaled iloprost
Quality of life

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on December 06, 2016