None listed
Conditions
Interventions
Sitaxsentan 100 mg tablet administered orally, once daily plus Sildenafil 20 mg tablet administered orally, three times a day
Sitaxsentan 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
Group name:Group 2 Type of group
Group 1 Type of group
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Previously enrolled in B1321001 and completed the 12-week study as planned • Evidence of having personally signed and dated the informed consent document indicating that the subject (or the legally accepted representative) has been informed about all relevant aspects of the study. • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical trial procedures. • You have a current diagnosis of symptomatic PAH • Has a functional class of the World Health Organization (CMS) of class m symptoms at the time of the first day of screening for the B132100L • Is> 16 and 40 Kg. At the time of the first screening for B1321001 • It had a walking distance in 6 minutes> 150 and <450 meters and the distance walked within 15% of one and the other in two consecutive tests at the time of screening of B1321001. • Had a ventilation-perfusion lung (V / Q) scan, spiral / helical / electron beam CT scan, or pulmonary angiogram within 3 years prior to At the time of the first screening day of B1321001 that showed no 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, angiography or selective pulmonary angiography should exclude chronic embolic thrombus disease. • Having had the diagnosis of PAH confirmed by cardiac catheterization within 6 months prior to the time of the first screening day for B1321001 • If you are with vasodilators, digoxin, diuretics, spironolactone, or oxygen, you were receiving them at a stable dose of at least 1 month prior to the time of the first day of screening for B1321001. • If you are on corticosteroids, you have been receiving a stable dose of prednisone <20 mg / day (or equivalent dose, if with another corticosteroid) at least 1 month prior to the time of the first day of screening for B1321001 • If you are on warfarin (Coumadin®) or other vitamin K antagonists, you have been receiving a stable dose of at least 1 month prior to the time of the first day of screening for B1321001; Qualification for the goal of international standardized reason (INR) is allowed. • If you are with calcium channel blockers, have been receiving at a stable dose of at least 1 month prior to the time of the first day of screening for B1321001 and were maintained during the study. • If you are on a medication that belongs to the statin drug class (eg, lovastatin, atorvastatin), you must have been receiving a stable dose at least 3 months prior to the day of the first screening for B1321001 and have been kept at Throughout the study. • Women with reproductive potential should use 2 medically acceptable contraceptive methods (at least 1 barrier method), have a negative pregnancy test at the Basal / Day 1 visit and agree to use reliable methods of contraception for at least 1 month after the final view of the study. Women who have been surgically sterilized or have at least two years of post menopause are not considered to have reproductive potential.
Exclusion criteria
Exclusion criteria: • Treated with a drug under investigation, other than Sitaxsentan Sodium in B1321001 or device that has not received regulatory approval within 30 days prior to Baseline / Day 1 or during the study. • You have a known allergy to the ingredients of the phosphodiesterase inhibitor (PDE) or Endothelin Receptor Antagonist (ETRA) drug classes or tablet excipients • You are taking or have an anticipated need for systemic (oral, intravenous (IV)) administration of cyclosporine A for the duration of the study. • You are taking any specific inhibitor of cytochrome P450 3 A4 (CYP3 A4) (eg, ketokonazol, itraconazole), protease inhibitors (eg, ritonavir, saquinavir), alpha blockers, nitrates or nitric oxide donors (eg, supplements arginine, nicorandil) in any way. • PAH treatment • If you use arginine supplements chronically, including HeartBai®. This must have been suspended at least 30 days prior to the first sight of the screening day for B1321001. • Had pulmonary function tests within 3 months prior to the first day of screening for B1321001 that revealed evidence of significant parenchymal lung disease • You have a known immunodeficiency virus (HIV) infection, being treated with or anticipated that you will need HIV-specific antiretroviral therapy. • Has a history of heart disease on the left side and / or clinically significant heart disease, • Has a history of portal hypertension or chronic liver disease, including hepatitis B and / or hepatitis C (with evidence of recent infection and / or active virus replication) defined as mild to severe liver dysfunction (Child-Pugh Class A-C). • You have uncontrolled systemic arterial hypertension evidenced by a sitting systolic blood pressure> 160 mni Hg or by a sitting dystolic blood pressure> 100 mmHg during Baseline. • Has hypotension defined as systolic blood pressure after sitting 5 minutes 1.5 times the normal upper limit range (ULN) of aspartate amino transferase (AST) and (or alanine amino transferase (ALT) during Baseline. • I experienced a Serious Adverse Event (SAE) categorized as a bleeding event while I was at B1321001. • You have chronic renal failure defined as serum creatinine> 2.5 mg / dL at the time of! day of the first screening to enter the study B1321001 or requires dialysis support. • It has a hemoglobin concentration <10g / dL during Baseline / Day 1. • History of obstructive sleep apnea (treated or untreated). • History of atrial septostomy. • You have a known inherited retinal degenerative disorder (such as retinitis pigmentosa) or a history of anterior arteritic ischemic optic neuropathy. • You have an untreated proliferative diabetic retinopathy. • History of a malignancy within 5 years prior to the first day of screening for B1321001, with the exception of localized skin or cervical carcinomas. • Other severe acute or chronic medical abnormality or laboratory abnormality which may increase the risk associated with participation in the study or administration of the research product or that may interfere with the interpretation of the study results, at the investigator´s judgment , which would make the subject inappropriate to enter this study • You 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 histo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between studys first dose date in and date when first clinical worsening event occurs. Measure:Time to Clinical Worsening (TTCW) Timepoints:Baseline, Weeks 12, 24 or Early Termination (ET) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline. Measure:Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) Timepoints:Baseline to Weeks 12 and 24 ; Outcome name:WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X. Measure:Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 Timepoints:Baseline, Weeks 12, 24 or ET ; Outcome name:SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline. Measure:Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain Timepoints:Baseline, Weeks 12, 24 and ET ; Outcome name:SF-36 is a standardized survey evaluating 8 aspects of functional health and well being | — |
Countries
Arabia Saudi, Argentina, Bulgaria, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, India, Malasya, Mexico, Peru, Philippines, Romania, Russian Federation, Serbia, Slovakia, South Africa, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactMARCO CAMERE
PFIZER S.A.
Outcome results
None listed