Status:
COMPLETED
Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed brea...
Eligibility Criteria
Inclusion
- Diagnosis of an interstitial lung disease (usual interstitial pneumonia \[UIP\], nonspecific interstitial pneumonia \[NSIP\] or sarcoidosis) with high resolution CT and a total lung capacity (TLC) ≤ 90% or scleroderma associated pulmonary arterial hypertension (PAH) with total lung capacity (TLC) ≤ 80%.
- Interstitial lung disease (ILD) must have been stable for at least 3 months (decrease in forced vital capacity (FVC)\< 10% and diffusing capacity of lung for carbon monoxide (DLco) \< 15 % in 3 months), i.e. no significant changes in pulmonary function testing and stable medication in terms of ILD (e.g., corticosteroids, immunosuppressants)
- Mean pulmonary vascular resistance (PVR) \> 400 dyne sec cm-5 or mean pulmonary arterial pressure (PAP mean) \> 30 mmHg
- Pulmonary capillary wedge pressure (PCWP) \< 15 mmHg
- Hemodynamic parameters at baseline (PAP, PCWP, cardiac output \[CO\], systemic mean arterial pressure \[SAP\])
- High resolution computer tomography (HRCT) (should not be older than 12 months prior start of the study)
- Heart rate \> 55 beats per minute (BPM) and \< 105 BPM at rest
- Systolic blood pressure (SBP) \> 90 mmHg
- World Health Organisation (WHO) functional class II, III and IV
- 6 Minute Walking Test (6MWT) \> 100m and \< 450 m
- Stable controlled arterial hypertension according to current guidelines
- Women of childbearing potential will be included in the study if the pregnancy test is negative and combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intra-uterine devices \[IUDs\]) is granted.
Exclusion
- Co-medication:
- Patients pretreated with specific medication for pulmonary arterial hypertension (PAH) like endothelin receptor antagonists, prostaglandins or phosphodiesterase type 5 (PDE 5) blockers are excluded from the trial.
- Requirement for concomitant use of nitrates are contraindicated.
- Pre-existing clinically relevant lung disease other than ILD including.
- Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) with a forced expiratory volume in one second (FEV1)/FVC \<60% pred., active tuberculosis
- Pulmonary hypertension of another WHO group (I, II, IV and V)
- Severe congenital abnormalities of the lungs, thorax and diaphragm
- Clinical or radiological evidence of a pulmovenoocclusive disease (PVOD)
- Systemic hemodynamics
- Acute or severe chronic left heart failure (ejection fraction (EF) \< 50%)
- Severe coronary artery disease (CAD; EF \< 50%); CAD patients must be asymptomatic and stable
- Congenital or acquired valvular or myocardial disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension
- Pulmonary function
- TLC predicted \< 30%
- FEV1 (related to FVC) \< 60% predicted
- Blood gases at room air
- Arterial partial carbon dioxide pressure (Pa CO2) \> 45 mmHg
- Arterial partial oxygen pressure (Pa O2) \< 50 mmHg at O2 supply \>/= 4 L/min
- Peripheral organ function
- Moderate or severe hepatic insufficiency (Child-Pugh Class Band C and/or total bilirubin \> 2.5 mg/dl (0.043 mmol/L); and/or hepatic transaminases \>3 upper limit normal \[ULN\])
- Moderate or severe renal insufficiency (creatinine \> 2 mg/dl) or creatinine clearance according to Cockroft-Gault formula \< 35 mL/ min
Key Trial Info
Start Date :
August 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00694850
Start Date
August 2 2008
End Date
July 3 2025
Last Update
July 28 2025
Active Locations (5)
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1
München, Bavaria, Germany, 81377
2
Giessen, Hesse, Germany, 35392
3
Hanover, Lower Saxony, Germany, 30625
4
Homburg, Saarland, Germany, 66421