Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00250640
• Date of registration: 07/11/2005
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
• Scientific title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years
• Date of first enrolment: April 2005
• Target sample size: 106
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00250640
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France, Germany, Italy, Portugal, Spain, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- The treating physician has chosen Ventavis as a suitable long-term treatment for the
patient

- Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial
Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA
functional class III (NYHA = New York Heart Association)

- No prior treatment with Ventavis or other active treatments for primary pulmonary
hypertension within 6 weeks of date of study inclusion (unless otherwise advised by
Bayer Schering Pharma)

Exclusion Criteria:

- Any condition that prevents participation in the study, including pregnancy and other
contraindications for Ventavis treatment (as listed in the current Ventavis Summary
of Product Characteristics and patient package insert)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Iloprost (Ventavis, BAYQ6256)

Primary Outcome(s)

The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. [Time Frame: Month 3 Visit]

Secondary Outcome(s)

Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. [Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years)]

The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. [Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years)]

Other safety variable [Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)]

Other safety variables (optional assessment) [Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)]

Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. [Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years)]

Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. [Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years)]

Secondary ID(s)

308120

91430

Source(s) of Monetary Support

Please refer to primary and secondary sponsors