None listed
Conditions
Interventions
Group 1 Type of group
Daily dose of 100 mg of sitaxsentan orally for 12 weeks
Group name:Group 2 Type of group
Daily dose of 100 mg of placebo similar to sitaxsentan orally for 12 weeks
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Evidence of a personally signed and dated consent document indicating that the subject (or his legally accepted representative) has been informed of all relevant aspects of the study. • Subjects who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures. • Have a current diagnosis of symptomatic PAH • Have symptoms of functional class or WHO. • Age> 16 and 40 kg. • Have distances> 150 and 150 and <450 meters. If the test results are not consistent, both 6MWT screening tests should be repeated 24 hours to 2 weeks after the first attempt, and the results should be within 15% of each other. If after this attempt, the subject is still ineligible, the subject will be considered a screening failure and entry into the study will be denied. • Have had a pulmonary ventilation-perfusion (V / Q) scan, electron beam / helical / spiral computed tomography (CT), or pulmonary angiogram within 3 years prior to screening that does not show evidence of thromboembolic disease (normal or low probability of pulmonary embolism). If a V / Q scan is abnormal (not normal or low probability), then a confirmatory CT or selective pulmonary angiography should exclude a chronic thromboembolic disease. • Having had the diagnosis of PAH confirmed by cardiac catheterization within 6 months prior to screening • If you have been receiving calcium blockers, at a stable dose for at least 1 month prior to screening and maintained throughout the study. • If you have been receiving vasodilators, digoxin, diuretics, spironolactone, or oxygen in a stable dose for at least 1 month prior to the study screening. • If corticosteroids have been received at a stable dose of ^ 0 mg / day of (or equivalent dose, if another corticosteroid) for at least 1 month prior to the study screening. If you are receiving treatment for CTD with any other drug, the doses should remain stable for the duration of the study. • If any medication belonging to the statin drug class p. ex. Lovastatin, atorvastatin, has been receiving a stable dose for at least 3 months prior to the study screening and maintained throughout the study. • If you have been receiving warfarin (Coumadin®) or another vitamin K antagonist in a stable treatment for at least 1 month prior to the study screening; the standardized international standardized rate (INR) is allowed. • Women with potential maternity should be using 2 medically acceptable forms of contraception (at least one barrier method), have a negative pregnancy test at screening and at baseline / day 1 and agree to use reliable methods of contraception for at least 1 month after the final study visit. Women who are surgically sterile or those who are post menopausal for at least 2 years are not considered maternity potential.
Exclusion criteria
Exclusion criteria: • Participation in other studies (with a research drug or device that has not received regulatory approval) within 30 days before the current study beginning (screening) and / or during participation in the study. • Prior exposure to an endothelin receptor antagonist (ETRA) such as sitaxittan, bosentan or ambrisentan. • Be taking, or have an anticipated need for systemic [oral, intravenous (IV)] administration of cyclosporine A for the duration of the study. • Chronic treatment for PAH within 30 days prior to the first day of study screening or during the study • Have uncontrolled systemic hypertension evidenced by a sitting systolic blood pressure> 160 mm Hg or a sitting diastolic blood pressure> 100 mm Hg in the screening. • Have pulmonary function tests within 3 months prior to screening that reveal evidence of significant parenchymal lung disease. • Have a history of portal hypertension or chronic liver disease, including hepatitis B and / or hepatitis C (with evidence of recent infection and / or active viral replication) defined as mild to severe hepatic impairment (Chile-Pugh class A-C). • Having a known human immunodeficiency virus infection, under treatment with or has an anticipated need for HIV-specific antiretroviral therapy. • Have hepatic dysfunction defined as aspartate amino transferase (AST) and / or alanine aminotransferase (ALT)> 1.5 times the upper limit of the normal range in screening. • Having chronic renal failure defined by a serum creatinine> 2.5 mg / d in the screening or requires dialysis support. • Have a hemoglobin concentration <10g / dL in the screening. • History of obstructive sleep apnea (treated or untreated). • History of atrial septostomy. • Have a history of heart disease on the left side and / or clinically significant heart disease, • History of malignancy within 5 years prior to screening, with the exception of localized carcinomas of the skin or cervix. • Other severe acute or chronic medical or laboratory abnormalities that may increase the risk associated with participation in the study or the administration of a product under investigation or that may interfere with the interpretation of the results of the study and, in the judgment of the investigator , would make the subject inappropriate to enter this study. • Have a psychiatric, addictive or other disorder that compromises the ability to give informed consent to participate in this study. This includes subjects with a recent history of alcohol or illicit drug abuse 30 days prior to Day 1 of the study screening and for the duration of the study. • Be currently pregnant or breastfeeding or intend to become pregnant for the duration of the study. • Be allergic to sitaxsentan ingredients or tablet excipients. • Researchers, study team or immediate family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:If 6MWD is not absent in week 12, the value of 6MWD in week 12 will be used in the primary efficacy analysis regardless of whether the subject has had a predefined clinical worsening event. If 6MWD is absent in week 12, the value absent in week 12 will be assigned with zero if the subject has had a predefined clinical worsening event, otherwise, the value absent in week 1! will be charged with the last 6MWD not absent based on the LOCF method. Measure:Change of 6MWD from baseline to week 12. Timepoints:week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The change from baseline in the WHO functional class (improvement, no changes, worsening) will be summarized with frequency counts and percentages per treatment group for each agency visit. The difference in treatment at week 12 will be analyzed using the CMH test, stratified by baseline 6MWD ( 310 meters) and the etiology of PAH (CTD and others). Measure:Change of WHO functional class from baseline to week 12 Timepoints:week 12 ; Outcome name:The time for clinical worsening is defined as any of the following: • Hospitalization due to worsening of PAH (defined as hospitalization for at least 24 hours caused by a clinical condition clearly related to PAH such as right heart failure, arrhythmia, syncope, endovenous diuretics or inotropic medications such as dobutamine, or by initiation of other specific therapies for PAH disease) • Death in the studio • Lung transplant or heart lung • Atrial septostomy, or • Withdrawal due to the addition of any of some chronic medications Measure:Time for clinical worsening Timepoints:12 weeks | — |
Countries
Bulgaria, Czech Republic, Peru
Contacts
Public ContactMARCO CAMERE
PFIZER S.A.
Outcome results
None listed