EUCTR2005-006192-13-DE进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Patients may be included in the study only if they meet all of the following:
- •1. Able and willing to give written informed consent and comply with study requirements.
- •2. Male or female patients aged 18-85 years
- •3. Have a current diagnosis of symptomatic PAH classified by one of the following: a) IPAH or FPAH; b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosus (PDA) = 1 year post-operative from Screening, d) PAH associated with HIV, or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
- •4. On a stable dose regimen of sildenafil, at doses between 60 mg and 300 mg/day in divided doses, for at least 12 weeks prior to screening, and tolerating sildenafil without clinically significant side effects
- •5. Screening 6-MWD of 100-450 meters
- •6. Have a cardiac catheterization either at baseline or within the previous 3 years consistent with PAH, with the following values: a) mean pulmonary artery pressure (mPAP) at rest > 25 mm Hg, b) pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure = 15 mm Hg, and c) pulmonary vascular resistance (PVR) = 240 dynes·sec·cm-5
- •7. Have pulmonary function tests showing FEV1/FVC ratio > 50% AND either a) total lung capacity > 70% predicted, or b) total lung capacity between 60% and 70% predicted, with no more than mild patchy interstitial lung disease on lung imaging
- •8. If HIV-seropositive, must have been stable with a) no concomitant active opportunistic infections and an undetectable viral load for the 6 months prior to screening, b) CD4+ T cell count > 200/mm3 and no change in antiviral regimen for the 3 months prior to screening, c) no change in antiviral regimen anticipated during the course of the study, and d) no use of inhaled pentamidine
- •9. Documented evidence of absence of thromboembolic disease (i.e., low probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest CT scan within 3 years of screening
- •10. If on corticosteroids, be receiving a stable dose of = 20 mg/day of prednisone or equivalent for at least 1 month prior to screening
- •11. Women of childbearing potential must agree to use an adequate method of contraception during the study and for one month after the last dose of study drug
- •12. Those patients receiving bosentan concurrently with sildenafil at the time of screening must have been on bosentan for at least 16 weeks, with stable liver transaminases (< 2X upper limit of normal) and on stable dose (maximum 125 mg BID) for at least the last 8 weeks prior to screening
- •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
- •Patients meeting any of the following criteria are not eligible to participate in the study:
- •1. Pulmonary arterial hypertension related to any etiology other than those specified in the inclusion criteria (including portopulmonary)
- •2. Receipt of any prostacyclin or prostacyclin analogue within 12 weeks before screening
- •3. Discontinuation of bosentan or other endothelin antagonist within 12 weeks before screening
- •4. Change in sildenafil dose within 12 weeks before screening
- •5. Any clinically significant ocular abnormality during screening examination that could be potentially related to sildenafil use (e.g. retinal abnormalities or visual defects)
- •6. History of poor tolerability to sildenafil
- •7. Untreated or inadequately treated obstructive sleep apnea
- •8. History of left-sided heart disease, including any of the following:
- •- aortic or mitral valve disease;
- •- pericardial constriction;
- •- restrictive or congestive cardiomyopathy;
- •- diastolic dysfunction syndrome;
- •- left ventricular ejection fraction < 40% by multigated radionucleotide angiogram
- •(MUGA), angiography, or echocardiography;
- •- left ventricular shortening fraction < 22% by echocardiography;
- •- symptomatic coronary disease with demonstrable ischemia;
- •- life-threatening cardiac arrhythmias
- •9. Cerebrovascular events (e.g. transient ischemic attack or stroke) within 6 months of screening
- •10. Chest X-Ray showing medically relevant disease other than findings consistent with PAH
- •11. Receipt of atrial septostomy within 6 months of screening
- •12. Any condition other than PAH which might affect the patient’s ability to perform a 6-MWT
- •13. Clinically relevant obstructive lung disease (e.g. asthma or COPD)
- •14. Clinically relevant abnormal laboratory values at screening that, in the opinion of the investigator, would compromise the evaluation of efficacy and/or safety of the study drug
- •15. Treatment with an investigational drug or device which has not received regulatory approval within 120 days before screening
- •16. Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
- •17. Systemic hypotension with systolic BP < 95 mmHg
- •18. Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis
- •19. Chronic liver disease or cirrhosis, including porto-pulmonary hypertension
- •20. Clinically relevant bleeding disorder or active bleeding
- •21. Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
- •22. Pregnant or breastfeeding
- •23. The addition or discontinuation of any new type of chronic treatment for PAH including, but not limited to calcium channel blockers within 12 weeks before screening; or vasodilators, digitalis, diuretics, oxygen, or investigational treatments within 30 days before screening; for all of these except diuretics, the dose must have been stable for 7 days prior to baseline. Anti-coagulant therapy may be modified at any time.
- •24. Concomitant use of medications that are contraindicated with sildenafil, including regular or intermittent use of organic nitrates
- •25. Are study investigators, study staff, or their immediate families
- •26. Concomitant therapy with medications contraindicated by bosentan labeling (cyclosporine, glyburide)
- •27. Any malignancy that may impact survival (<1 year expected survival), infiltrate the lungs, require contradicted or excluded concomitant medications, or caus
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