SPHERA: Efficacy of Ventavis Used in Real-life Setting.

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01355380
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Actual Duration (Months): 73.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled iloprost (Ventavis, BAYQ6256)

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
• Actual Study Start Date: Aug 5, 2010
• Actual Primary Completion Date: Apr 28, 2016
• Actual Study Completion Date: Sep 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Changes of the exercise capacity as measured by 6-minutes walking distance [3, 6, 9 and 12 months vs. baseline]

Secondary Outcome Measures

1. Changes of depression score over time [3, 6, 9 and 12 months vs. baseline]

2. Changes of functional capacity as measured by WHO classification system [3, 6, 9 and 12 months vs. baseline]

3. Changes of pulmonary haemodynamics [3, 6, 9 and 12 months vs. baseline]

4. Changes of serum level of natriuretic peptide B [3, 6, 9 and 12 months vs. baseline]

5. Changes of Quality of Life score [3, 6, 9 and 12 months vs. baseline]

6. Changes in cardiac echo parameters [3, 6, 9 and 12 months vs. baseline]

7. Number of patients with treatment-emergent adverse events [Up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Poland

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01355380
• Other Study ID Numbers: 15308; VE1010PL
• First Posted: May 18, 2011
• Last Update Posted: Oct 17, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Bayer: Pulmonary arterial hypertension; Inhaled iloprost; Quality of life
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Iloprost

Study Results

No Results Posted as of Oct 17, 2017