EUCTR2008-005887-14-SK进行中（未招募）1 期
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
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK0 个研究点目标入组 150 人开始时间: 2009年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Previously enrolled in B1321001 and completed the 12-week study as planned.
- •2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •4. Has a current diagnosis of symptomatic PAH classified by one of the following:
- •a. Idiopathic, primary or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH)
- •b. PAH associated with one of the following connective tissue diseases:
- •i. Systemic sclerosis (scleroderma)
- •ii. Limited scleroderma
- •iii. Mixed connective tissue disease
- •iv. Systemic lupus erythematosus
- •v. Overlap syndrome
- •c. Exposure to drugs and toxins (e.g., anorexigens, L-tryptophan, toxic rapeseed oil)
- •5. Has World Health Organization (WHO) functional class III symptoms at the time of the first screening day for B1321001.
- •6. Is =16 and =80 years of age (at the time of the first screening day for B1321001).
- •7. Has a body weight of =40 kg at the time of the first screening day for B1321001.
- •8. Had 6-minute walk distances =150 and =450 meters and distances walked within 15% of one another on two consecutive tests at the time of B1321001 screening.
- •9. Had a ventilation-perfusion (V/Q) lung scan, spiral/helical/electron beam computed tomography (CT), or pulmonary angiogram within 3 years prior to the time of the first screening day for B1321001 that shows no evidence of thromboembolic disease (normal or low probability for pulmonary embolism). If a V/Q scan is abnormal (not normal or low probability), then a confirmatory CT, angiography or selective pulmonary angiography must exclude chronic thromboembolic disease.
- •10. Had the diagnosis of PAH confirmed by a cardiac catheterization within 6 months prior to the time of the first screening day for B1321001 with the following values:
- •a. Mean pulmonary artery pressure (mPAP) >25 mmHg (at rest)
- •b. Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure =15 mm Hg; and
- •c. Pulmonary vascular resistance (PVR) >3 mm Hg/L/min or 240 dynes*sec/cm5
- •11. If on vasodilators, digoxin, diuretics, spironolactone, or oxygen was receiving a stable dose for at least 1 month prior to the time of the first screening day for B1321001.
- •12. If on corticosteroids, was receiving a stable dose of =20 mg/day of prednisone (or equivalent dose, if other corticosteroid) for at least 1 month prior to the time of the first screening day for B1321001.
- •13. If on warfarin (Coumadin®) or other vitamin K antagonists, was receiving stable treatment for at least 1 month prior to the time of first screening day for B1321001; titration to target international normalized ratio (INR) is permitted.
- •14. If on calcium channel blockers, was receiving a stable dose for at least 1 month prior to the time of first screening day for B1321001 and was maintained throughout the study.
- •15. If on any medication belonging to the statin drug class (eg, lovastatin, atorvastatin), was receiving a stable dose for at least 3 months prior to the time of first screening day for B1321001 and was maintained throughout the study.
- •16. Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method), have a negative pregnancy test at Baseline/Day 1 and agree to use reliable methods of contraception for at lea
排除标准
- •1. Treated with an investigational drug, other than sitaxsentan sodium in B1321001, or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
- •2. Has a known allergy to ingredients of Phosphodiesterase (PDE) inhibitor or Endothelin Receptor Antagonist (ETRA) drug classes or the tablet excipients.
- •3. Is taking, or has an anticipated need for systemic administration (oral, intravenous (IV)) of cyclosporine A for the duration of the study.
- •4. Is taking any specific cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ketoconazole, itraconazole), protease inhibitors (eg, ritonavir, saquinavir), alpha blockers, nitrates or nitric oxide donors (eg, arginine supplement, nicorandil) in any form.
- •5. Treatment for PAH with any of the following within 30 days prior to the time of first screening day for B1321001, during the B1321001 study, or an anticipated needed during the B1321003 study:
- •a. Any chronic intravenous or subcutaneous prostacyclin or prostacyclin analogue
- •b. Any alternative phosphodiesterase-5 (PDE-5) inhibitor
- •c. Any alternative ETRA
- •d. Intravenous inotropes; or
- •e. Inhaled nitric oxide (excluding acute vasodilator testing during diagnostic cardiac catheterization)
- •6. Is using chronic arginine supplementation including HeartBar®. This must have been stopped for at least 30 days prior to the time of first screening day for B1321001.
- •7. Had pulmonary function tests within 3 months prior to the time of the first screening day for B1321001 that reveal evidence of significant parenchymal lung disease. Parenchymal lung disease is defined as:
- •a. Total lung capacity (TLC) <70% (predicted)
- •b. Forced expiratory volume in 1 second FEV1 =70% (predicted), or
- •c. Forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) =60%
- •8. Has known human immunodeficiency virus (HIV) infection, under treatment with or has anticipated need for HIV specific antiretroviral therapy.
- •9. Has history of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
- •a. Repaired or unrepaired congenital heart disease (CHD)
- •b. Aortic or mitral valve disease (stenosis or regurgitation) defined as more than minimum aortic insufficiency and more than moderate mitral regurgitation
- •c. Pericardial constriction
- •d. Restrictive or congestive cardiomyopathy
- •e. Left ventricular ejection fraction <40% by multiple gated acquisition scan (MUGA), angiography or echocardiography
- •f. Left ventricular shortening fraction <22% by echocardiography
- •g. Symptomatic coronary disease with demonstrable ischemia; or
- •h. Evidence of left ventricular hypertrophy or diastolic dysfunction obtained by electrocardiogram or echocardiography within 3 months prior to the time of the first screening day for B1321001. Echocardiographic (ECHO) evidence of concentric remodeling and/or diastolic dysfunction is defined as 1 or more of the following within 3 months prior to the time of the first screening day for B1321001:
- •i. Left ventricular mass =125 g/m2
- •ii. Left atrial diameter =4.5 cm
- •iii. Wall thickness of =11 mm
- •iv. Relative wall thickness of 2 times wall thickness ÷ radius being =0.45 mm
- •10. 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 hepatic impairment (Child-Pugh Class A-C).
- •11. Has uncontrolled systemic hypertension as eviden
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