A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

PFIZER S.A.,0 个研究点目标入组 0 人开始时间: 2009年9月17日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: PFIZER S.A.,

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•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 <80 years old (at the time of the first screening day for B1321001)
•It has a body weight> 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.

排除标准

•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 <90 mm Hg during Baseline.
•Has liver dysfunction, defined as> 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

研究者

发起方

PFIZER S.A.,

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