Clinical trial NCT00250640: Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Primary Pulmonary hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries

Brief summary: This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: Month 3 Visit
Secondary outcomes:
measure: 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.
timeFrame: all scheduled visits (Study period is min. 2 years and max. 4 years)
measure: 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.
timeFrame: all scheduled visits (Study period is min. 2 years and max. 4 years)
measure: Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.
timeFrame: all scheduled visits (Study period is min. 2 years and max. 4 years)
measure: The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.
timeFrame: all scheduled visits (Study period is min. 2 years and max. 4 years)
measure: Other safety variable
timeFrame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
measure: Other safety variables (optional assessment)
timeFrame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Other outcomes:
Locations:
city: Brest
country: France
city: Clamart Cedex
country: France
city: Lille
country: France
city: Lyon Cedex 03
country: France
city: Pessac
country: France
city: Reims
country: France
city: Strasbourg
country: France
city: Vandoeuvre les Nancy Cedex
country: France
city: Donaueschingen
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Löwenstein
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Gießen
country: Germany
state: Hessen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Homburg/Saar
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Erfurt
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Bologna
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Madrid
country: Spain
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: