Overview

This trial is active, not recruiting.

Condition pulmonary hypertension
Treatment ventavis inhaled (iloprost, bayq6256)
Sponsor Bayer
Start date February 2011
End date February 2017
Trial size 160 participants
Trial identifier NCT01389271, 14990, VE0910TR

Summary

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
ventavis inhaled (iloprost, bayq6256)
Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.

Primary Outcomes

Measure
6 Minutes walking distance (change in meters)
time frame: At month 48
Adverse events, weight, vital findings
time frame: At month 48

Secondary Outcomes

Measure
6 Minutes walking distance (% change)
time frame: At month 48
New York Heart Association Functional Class
time frame: At month 48
Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change
time frame: At month 48
Pulmonary hypertension related hospitalization
time frame: At month 48
Heart and/or lung transplantation, mortality
time frame: At month 48

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old. - Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV. - Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV. - Patients who signed written informed consent. Exclusion Criteria: - Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision; - Severe arrhythmias; - Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months. - Pulmonary hypertension due to venous occlusive disease. - Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. - Pregnancy and lactation - Age below 18

Additional Information

Official title Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.