PER-026-09已完成未知
A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
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
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
- •One of the following scenarios must be applicable: Previously enrolled in the B1321001 for at least 4 weeks, it was discontinued from the study after the Awarding Committee gave the discontinuation based on an early withdrawal or the need to add or increase the dose of a chronic medication for an aggravating PAH, or previously enrolled in B1321003, discontinued from the study after the Adjudication Committee gave discontinuation based on an Early Discontinuation due to the need to add or increase the dose of a chronic medication for a PAH make it worse, or complete the B1321003 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.
- •It has a body weight> 40 Kg. At the time of the first screening for B1321001.
- •If you are on a medication that belongs to the statin drug class (eg, lovastatin, atorvastatin), you must have been receiving a stable dose for at least 3 months prior to the day of the first screening for B1321001 and it has been maintained 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
- •Treatment with a drug under investigation (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or use of a device that has not received regulatory approval within the previous 30 days of Baseline / Day 1 or during the study.
- •You are taking or have an anticipated need for systemic (oral, intravenous (IV)) administration of cyclosporine A for the duration of the study.
- •Subjects who use arginine supplements chronically, including HeartBar®. This must have been suspended at least 30 days before the screening day view for B1321001.
- •You have uncontrolled systemic arterial hypertension evidenced by a sitting systolic blood pressure> 160 mm Hg or by a sitting diastolic blood pressure> 100 mm Hg during Baseline / Day 1.
- •You have hypotension defined as systolic blood pressure after sitting 5 minutes <90 mm Hg during Baseline / Day 1.
- •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 impairment (Child-Pugh Class A-C).
- •You have 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 / Day 1.
- •It was discontinued from B1321003 due to> 3 times the upper limit of normal AST or ALT or> 2 times the upper limit of normal total bilirubin; or AST or ALT> 5 times the upper limit of normal.
- •Experienced a Serious Adverse Event (SAE) categorized as a bleeding event while on B1321003.
- •You have chronic renal failure defined as serum creatinine> 2.5 mg / dL at the time of the first screening for B1321001 or require dialysis support.
- •It has a hemoglobin concentration <10 g / dL during Baseline / Day 1.
- •History of obstructive sleep apnea (treated or untreated).
- •History of atrial septostomy.
- •You have a known hereditary degenerative retinal disorder (such as retinitis pigmentosa) or a history of non-arthritic anterior ischemic optic neuropathy.
- •You have an untreated proliferative diabetic retinopathy.
- •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 history of alcohol or illicit drug abuse within 30 days prior to the first day of screening for B1321001 and for the duration of the study.
- •You are currently pregnant or breastfeeding or intend to become pregnant for the duration of the study.
- •Researchers, study staff or their immediate family members.
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