Trial Condition(s):
Pulmonary hypertension
Inhaled Iloprost in the treatment of patients with pulmonary hypertension up to 4 years (OPTION)
Bayer Identifier:
14990
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Turkey | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Open-label, uncontrolled, prospective long-term observation of Inhaled Iloprost in the treatment of patients with pulmonary hypertension up to 4 years
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 6 Minutes walking distance (change in meters)Timeframe: At month 48
- Adverse events, weight, vital findingsTimeframe: At month 48
Secondary Outcome
- 6 Minutes walking distance (% change)Timeframe: At month 48
- New York Heart Association Functional ClassTimeframe: At month 48
- Change in drug dosage or frequency, need for PAH specific drug combination, need for drug changeTimeframe: At month 48
- Pulmonary hypertension related hospitalizationTimeframe: At month 48
- Heart and/or lung transplantation, mortalityTimeframe: At month 48
Additional Information
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