EUCTR2006-001464-23-DE进行中（未招募）不适用
A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK0 个研究点目标入组 106 人开始时间: 2006年5月5日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
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. Subjects aged 18 and above at the time of the screening visit who have any of the following types of pulmonary arterial hypertension and functional class, and for which bosentan therapy is indicated according to EU Marketing Authorisation:
- •·Idiopathic ‘Primary’ Pulmonary Arterial Hypertension (PAH)
- •.Pulmonary Hypertension secondary to Scleroderma.
- •·Subjects with WHO functional class III prior to initiation of bosentan therapy.
- •2. Subjects must have been treated continually with a stable dose of bosentan (62.5mg bid or 125mg bid) for a minimum of three months prior to randomization.
- •3. Subject with a mean pulmonary artery pressure =25 mmHg and a pulmonary capillary wedge pressure of < 15 mmHg at rest, via right heart catheterization within 3 years prior to randomization.
- •4. Subjects whose baseline 6-Minute Walk Test distrance is =100m and =450m.
- •5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •7. All women of childbearing potential must have a negative screening serum pregnancy test and:
- •? Must agree to use a highly effective method of contraception (ie, hormonal in conjunction with intrauterine device or barrier methods with spermicide) throughout the study and for the duration of their bosentan therapy or
- •? Must be celibate or
- •? Their partner must have had vasectomy.
- •8. Women who are not of childbearing potential may be enrolled and do not need to use birth control, provided they meet at least one of the following criteria:
- •? Have undergone hysterectomy or bilateral oopherectomy or
- •? Have medically confirmed ovarian failure or
- •? Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria. 2. With the exception of bosentan therapy, subjects who are currently receiving any forms of chronic treatment for PAH such as any formulations of prostacyclin, PDE-5 inhibitors, other endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplements) including nicorandil in any form or any potent CYP3A4 inhibitors (e.g. Cyclosporin A and Glibenclamide). 3. Subjects with significant (i.e. > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation. Subjects with previous surgical replacement of a valve may be eligible for entry into the study after consultation with a Pfizer study clinician provided the following conditions are satisfied:That there was no evidence of PAH secondary to valvular disease prior to surgery; The prosthetic valve is functioning normally on echocardiography; The valve replacement occurred at least one year prior to randomization. 4. Subjects with acutely decompensated heart failure within 30 days prior to randomization. 5. Subjects with LV Ejection Fraction of <45% or LV shortening fraction of <0.2 within three months prior to randomization. 6. Subjects who have had a myocardial infarction within 6 months prior to randomization 7. Subjects who have had a change of dose or class of standard background therapy used for treatment of PAH (i.e. oxygen, calcium channel blockers, digoxin, diuretics) used for the treatment of PAH within 30 days prior to randomization. Note: a change in the dose or oral anticoagulant therapy within this timeframe to maintain the INR within the therapeutic range is acceptable. 8. Subjects with congenital heart disease (unless they fulfill inclusion 1.), pulmonary hypertension due to thromboembolism, HIV or schistosomiasis. 9. Subjects who have undergone atrial septostomy within six months prior to randomization. 10. Subjects with uncontrolled brady- or tachyarrhythmias, placement of pacemakers orimplantable defibrillators <60 days prior to randomization. 11. Subjects whose 6 Minute Walk Test distance may be limited by conditions other than PAH related dyspnoea or fatigue e.g. claudication from vascular insufficiency or arthritis. 12. Pregnant or lactating women. 13. Subjects with a history or pulmonary embolism verified by ventilation/perfusion scan, angiogram or spiral chest CT scan. 14. Subjects with hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at either screening or baseline. 15. Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION). 16. Subjects with history of chronic lung diseases / restrictive lung disease (e.g. COPD or scleroderma) with impairment of lung function as defined by TLC <60% and/or FEV1 =80% predicted within 30 days or randomization. 17. Subjects who have previously failed on bosentan or sildenafil therapy (defined as those subjects who had no evidence of clinical improvement whilst on the medicines, and no worsening in symptoms or clinical status, on discontinuation of the medicines). 18. Subjects at screening with impairment of renal function (serum creatinine > 2.5 X Upper Limits of Normal (ULN)). 19. Subjects at screening with severe hepatic impairment (ALT/AST > 3X ULN) or portalpulmonary hypertension. 20. Subjects using chronic arginine supplementati
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