Pulmonary hypertension associated with chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: Not Applicable - Name not assigned
Product Code: UK-369,003
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: UK-369,03
Other descriptive name: N
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged > 40 and 100m and 20mmHg by right heart catheter during screening or within 3 months prior to the baseline visit (V1) (as long as these subjects with measurements before baseline visit (V1) have been stable with no worsening of their COPD that has resulted in changes in class of medication or treatment with antibiotics for a presumed pulmonary infection, or hospitalization since their catheter). 7. Subjects who are capable of giving written informed consent to participate in the study. 8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of asthma, allergic rhinitis or atopy 2. Subjects with a history of other chronic pulmonary disease eg tuberculosis, lung cancer, cystic fibrosis, interstitial lung disease, known obstructive sleep apnoea or with significant restrictive lung disease (with a FEV1/FVC>70% post nebuliser) eg respiratory muscle weakness, or lung fibrosis 3. Subjects who have had previous lung volume reduction surgery 4. Subjects on continuous long term oxygen therapy for >15 hours per day 5. Subjects with primary PH or PH associated with other lung disease other than COPD eg thromboembolism, HIV, congestive heart failure or schistosomiasis, sarcoid, tuberculosis or bronchiectasis, connective tissue disease etc 6. Subjects who have had a new class of COPD or cardiopulmonary medication (eg diuretic, steroids) or change in class of these medications initiated within 6 weeks prior to entering the study at screening visit 7. Subjects with a history of pulmonary embolism verified by ventilation/perfusion scan, angiogram or spiral chest CT scan within 6 months of randomization 8. Subjects with congenital heart disease 9. Subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation, or subjects with previous valvular surgery 10. Subjects with a left ventricular ejection fraction (LVEF) less than 45% or LV shortening fraction 35kg/m2 18. Subjects with severe impairment of hepatic function, Child-Pugh Class C (Appendix 7 of the protocol), or portal PH 19. Pregnant or lactating women or women of child bearing potential (i.e those who are not post-menopausal or surgically sterilised). Women who have undergone tubal ligation should be excluded. 20. Subjects who have previously received chronic oral sildenafil or any other PDE5 inhibitor for any reason for a period exceeding 5 days 21. Subjects who have taken sildenafil or any other PDE5 inhibitor in the 48 hours prior to screening and who are unwilling to cease taking this therapy for the duration of the study. Subjects who have received any PDE4 inhibitor in the 48 hours prior to screening (see exclusion 23) 22. Subjects who are currently receiving any form of nitrates or nitric oxide donors (including nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, alpha blockers, [Subjects previously receiving any of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of UK-369,003MR on exercise capacity as measured by change frombaseline in distance walked during the 6 Minute Walk Test (6MWT) after 12 weeks of treatment in subjects with PH associated with COPD.;Secondary Objective: 1. To evaluate the effects of UK-369,003MR on health related quality of life as measured by the St George’s Respiratory Questionnaire. 2. To evaluate the effects of UK-369,003MR on exertional dyspnea as measured by the Borg dyspnea score. 3. To evaluate the safety and tolerability of UK-369,003MR in subjects with COPD associated PH. 4. To evaluate the effects of UK-369,003MR on resting PaO2. 5. To evaluate the effects of UK-369,003MR on the maximum oxygen desaturation during the 6MWT 6. To evaluate the effects of UK-369,003MR on spirometry. 7. To investigate the population pharmacokinetic parameters in these subjects. 8. To investigate the effects of UK-369,003MR on time to clinical worsening.;Primary end point(s): Change from baseline in total distance walked during a 6MWT at week 12 of the study | — |
Countries
Germany, United Kingdom
Outcome results
None listed