Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

Pulmonary Hypertension Clinical Trial

— OPTION  

Official title:

Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389271
• Other study ID #: 14990
• Secondary ID: VE0910TR
• Status: Completed
• Start date: February 3, 2011
• Est. completion date: June 18, 2018

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 18, 2018
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minutes walking distance (change in meters)		At month 48
Primary	Adverse events, weight, vital findings		At month 48
Secondary	6 Minutes walking distance (% change)		At month 48
Secondary	New York Heart Association Functional Class		At month 48
Secondary	Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change		At month 48
Secondary	Pulmonary hypertension related hospitalization		At month 48
Secondary	Heart and/or lung transplantation, mortality		At month 48

External Links

•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.