A study to assess the effectiveness of Riociguat when it is used in patients who have an operable form of CTEPH. The effectiveness of Riociguat will be studied in those patients prior to undergoing the operation (known as Pulmonary Endarterectomy)
- Conditions
- Chronic Thromboembolic Pulmonary Disease (CTEPH)MedDRA version: 20.0Level: LLTClassification code 10068740Term: CTEPHSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001121-40-GB
- Lead Sponsor
- International CTEPH Association (ICA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 88
Each patient must meet all of the following criteria to be enrolled in this study:
1. Is a male or nonpregnant and nonlactating female patient aged from 18 to 80 years, both inclusive
2. Is diagnosed with operable CTEPH and anticipating symptomatic and/or prognostic benefit from PEA
3. Has PVR >800 dyn·s·cm-5
4. Has undergone RHC not more than 180 days before Visit 1
5. Has been treated with anticoagulants for at least 90 days before Visit 1
6. Has ability to swallow oral medication
7. Has ability and willingness to participate and access to the health facility
8. Is capable of understanding the written informed consent and provides signed and witnessed written informed consent
9. Female patient must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence)
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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
Patients meeting any of the following criteria will be excluded from the study:
1. Has unstable disease in need of urgent PEA surgery as determined by the treating physician
2. Has known hypersensitivity, allergic, or adverse reactions to riociguat or any of the excipients comprising riociguat tablets
3. Has known active hepatitis A immunoglobulin M, hepatitis B surface antigen, or hepatitis C antibody
4. Is human immunodeficiency virus positive
5. Has pulmonary veno-occlusive disease
6. Has symptomatic hypotension
7. Has symptomatic carotid disease
8. Has significant coronary atherosclerotic disease in need of intervention
9. Has severe left heart disease in need of intervention
10. Has redo sternotomy
11. Has received any background therapy for PAH in the preceding 30 days before Visit 1 including ERAs, PDE5 inhibitors, or prostanoids
12. Is receiving nitrates, NO donors (eg, amyl nitrite), ERAs, prostanoids, specific PDE5 inhibitors, nonspecific phosphodiesterase inhibitors (eg, dipyridamole, theophylline)
13. Is receiving strong cytochrome P450 and P-glycoprotein/breast cancer resistance protein inhibitors
14. Is receiving strong cytochrome P450 3A inducers
15. Has creatinine clearance <15 mL/min or is on any form of dialysis
16. Has severe hepatic impairment classified as Child-Pugh B or C
17. Has received an investigational drug within the past 4 weeks before Visit 1
18. Is a lactating or pregnant (as demonstrated by a serum or urine dipstick pregnancy test) woman, or not willing to take measures not to become pregnant during the 3 month treatment study period and 1 month after the last dose of study drug administered
19. Has smoked or used tobacco in any form, including snuff or chewing within 3 months prior to Visit 1
20. Has idiopathic interstitial pneumonitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method