Patients with interstitial lung disease associated pulmonary hypertension MedDRA version: 21.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: riociguat 0.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descript
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following inclusion criteria must be met at the pre-study examination: Men and women aged > 18 years. Diagnosis of an interstitial lung disease (UIP, NSIP or sarcoidosis) with high resolution CT and a total lung capacity (TLC) 100 m and 400 dyne sec cm-5 or PAP mean > 30 mmHg PCWP > 15 mmHg Hemodynamic parameters at baseline (PAP, PCWP, CO, SAP). HRCT (should not be older than 12 months prior start of the study). Heart rate > 55 BPM and 90 mmHg Women of childbearing potential will be included in the study if the pregnancy test is negative and combination of condoms with a safe and higly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs) is granted. Completion of a physical examination. Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period. Subjects must have given their written informed consent to participate in the study after receiving adequate previous infomation and prior to any study specific procedures. Right-heart catheterisation for measurement of hemodynamic paramters and HRCT for the definite diagnosis of ILD associated PH must have been performed independently of this study. Hemodynamic measurement results should not be older than 3 months ad HRCT must not be older than 12 months at study start. 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: The following factors determined at the pre-study examination will automatically exclude the patient from participating in the trial: Co-medication: Patients pretreated with an off label use of specific medication for PAH like endothelin receptor antagonists, prostaglandins or 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 COPD with a FEV1/FVC30% FEV1 (related to VC) 45 mmHg -PaCO2 2.5mg/dl (43 µmol/L); and/or hepatic transaminases > 3 ULN. -Moderate or severe renal insufficiency (creatinine > 2 mg/dl) or creatinine clearance according to Cockroft-Gault formula < 35 mL/min. Others Previous therapeutic radiation of lungs or mediastinum. Concomitant participation in anoter trial or study. Therapy with another investigational product within 30 days prior start of the study. Women with pregnancy, breast feeding or with childbearing potential lacking combination of condoms and a safe and highly effective contraception method (hormonal contraception wth implants or combined oral contraceptives, certain IUDs). Patients whose underlying disease is not likely to permit them to survive the study. Excluded Therapies (see section 4.5.7)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is to investigate the safety and tolerability of a 12-week treatment with BAY 63-2521 of patients with pulmonary hypertension due to intestinal lung disease (ILD idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, sarcoidosis, scleroderma. ;Secondary Objective: Secondary objectives of the study are to assess the efficacy parameters and pharmacokinetics of BAY 63-2521 during the course of the study in patients with pulmonary hypertension due to interstitial lung disease.;Primary end point(s): safety and efficacy (AEs);Timepoint(s) of evaluation of this end point: main phase 12 weeks followed by a long term extension until approval and commercially available | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): pharmacokinetics and efficacy: Pharmacokinetics 6MWT modified Borg dyspnea score Quality of life assessments (SF-36; Euroqol) Hemodynamic parameters Laboratory samples Electrocardiogram (ECG) Blood Pressure and heart rate ;Timepoint(s) of evaluation of this end point: For all: Main phase 12 weeks followed by a long term extension (LTE). Pharmacokinetics, modified Borg dyspnea score, Quality of life assessments (SF-36; Euroqol), Hemodynamic parameters, Laboratory samples, Electrocardiogram (ECG) stopped during LTE with amendment 4. 6MWT and heart rate ongoing until approval and commercially available. | — |
Countries
Germany
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed