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Phase 1

• Conditions: Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks; MedDRA version: 16.1Level: LLTClassification code 10036727Term: Primary pulmonary hypertensionSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002783-12-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-18
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Male or female aged = 18 years.
2.Written informed consent given. [This consent must have been given before any study-specific procedures are conducted. A single informed consent form will cover both the main study, Parts 1–3, and the extension, Part 4.]
3.Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
4.Current inhalative therapy with 5 µg iloprost using the I Neb nebulizer.
5.WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost.
6.Hemodynamic diagnosis of PAH showing mean pulmonary arterial pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) < 15 mmHg and pulmonary vascular resistance (PVR) > 320 dyn•s•cm–5.
7.Ability to understand and follow study-related instructions.
8.If non-specific types of chronic treatment for PAH are being administered: Stable dosage of these for at least the 4 weeks up to screening.
9.If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these for at least the 3 months up to screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Related to pulmonary disease / PAH
1.PAH related to any etiology other than those specified in the inclusion criteria, especially pulmonary veno-occlusive disease (PVOD)
2.Documented evidence of thromboembolic disease (probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest computed tomography (CT) scan within the 3 years before the screening visit
3.Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease, COPD)
4.Receipt of atrial septostomy within the six months before the screening visit
Related to cardiovascular disease
5.Severe coronary heart disease or unstable angina
6.Myocardial infarction within the six months before the screening visit
7.Decompensated cardiac failure if not under close medical supervision
8.Severe arrhythmias
9.Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
10.Cerebrovascular events (e.g. transient ischemic attack or stroke) within 3 months before Screening Visit
11.Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
12.Systemic hypotension with systolic blood pressure < 85 mmHg
Related to other conditions
13.Hypersensitivity to the active substance or to any of the excipients
14.Conditions where the effects of Ventavis on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage)
15.Hepatic impairment (such as acute hepatitis, chronic active hepatitis, or liver cirrhosis Child-Pugh B, C)
16.Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL and/or the requirement for dialysis
17.Clinically relevant bleeding disorder or active bleeding
18.Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
19.Clinically relevant abnormal conditions (including laboratory values) at Screening Visit that, in the opinion of the investigator, would compromise the evaluation of the study drug
Related to prior and concomitant medication
20.Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before Screening Visit
21.Addition or dose change of non-specific type of chronic treatments for PAH such as calcium channel blockers, nitrates, digitalis, or diuretics within 4 weeks before Screening Visit
22.Treatment with an investigational drug or device which has not received regulatory approval within 4 weeks before Screening Visit or during study
23.Any kind of prostanoid other than those mentioned in inclusion criteria no. 9 within a period shorter than 5 half-lives before treatment
Others
24.Pregnant or breastfeeding women
25.Woman of child-bearing potential does not agree to use an adequate method of contraception, i.e. a combination of two effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study
26.Investigators, study staff, or their immediate families
27.Criteria which in the opinion of the investigator preclude participation for scientific reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified