EUCTR2006-001464-23-CZ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 CT13 9NJ0 个研究点目标入组 106 人开始时间: 2006年4月21日最近更新:
适应症
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 distance is =100m and =450m.
- •5. Subjects who have given written informed consent to participate in the study before being screened for the study.
- •6. All women of childbearing potential must use adequate contraception (i.e. 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. The screening serum pregnancy test must be negative. Women who have been surgically sterilized or are at least two years postmenopausal may be enrolled and do not need to use birth control.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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). Note: Acute vasodilator response testing with any short acting vasodilators such as prostacyclin or inhaled NO during right heart catherization is permitted.
- •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.), pulmonaryhypertension 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 PAHrelated 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 orscleroderma) 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 UpperLimits of Normal (ULN)).
研究者
相似试验
进行中（未招募）
1 期
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/APulmonary Arterial HypertensionEUCTR2006-001464-23-GBPfizer Ltd103
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/APulmonary Arterial HypertensionEUCTR2006-001464-23-GRPfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ106
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 three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension.MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary Arterial HypertensionEUCTR2006-001464-23-DEPfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK106
进行中（未招募）
1 期
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsRelapsing Remitting Multiple SclerosisMedDRA version: 5.1Level: PTClassification code 10028245EUCTR2004-003943-28-ESTeva Pharmaceutical Industries Ltd264
进行中（未招募）
1 期
A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).Relapsing remitting multiple sclerosisMedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-003647-30-BETeva Pharmaceutical Industries Ltd2,199