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

Hypertension, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250640
• Other study ID #: 91430
• Secondary ID: 308120
• Status: Completed
• Phase: N/A
• First received: November 7, 2005
• Last updated: January 30, 2015
• Start date: April 2005
• Est. completion date: July 2012

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesGermany: Federal Institute for Drugs and Medical DevicesPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesItaly: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Month 3 Visit	No
Secondary	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.		all scheduled visits (Study period is min. 2 years and max. 4 years)	No
Secondary	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.		all scheduled visits (Study period is min. 2 years and max. 4 years)	No
Secondary	Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.		all scheduled visits (Study period is min. 2 years and max. 4 years)	No
Secondary	The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.		all scheduled visits (Study period is min. 2 years and max. 4 years)	Yes
Secondary	Other safety variable	Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation	At all scheduled visits (Study period is min. 2 years and max. 4 years)	Yes
Secondary	Other safety variables (optional assessment)	Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses	At all scheduled visits (Study period is min. 2 years and max. 4 years)	Yes

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