EUCTR2005-006192-13-ES进行中（未招募）1 期
Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIO
CoTherix, Inc0 个研究点目标入组 180 人开始时间: 2006年5月12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
- 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 18-80 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 20 mg TID and 80 mg TID, for at least 12 weeks prior to screening, and tolerating sildenafil without clinically significant side effects
- •5. Screening 6-MWD of 100-425 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
- •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
- •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. Receipt 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
研究者
相似试验
进行中（未招募）
1 期
Estudio aleatorio, doble-ciego, controlado con placebo que evalúa la seguridad y eficacia de A-60444 en adultos con una infección por el VRS después de un trasplante de células madre.EUCTR2004-003657-99-ESArrow Therapeutics Ltd22
进行中（未招募）
不适用
Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGEspondilitis anquilosante___________________________Ankylosing SpondylitisMedDRA version: 12.0Level: LLTClassification code 10002556Term: Ankylosing spondylitisEUCTR2009-016068-35-ESSanofi-aventis Recherche & Développement300
进行中（未招募）
1 期
Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrenteEUCTR2006-002633-20-ESGlaxoSmithKline S.A
进行中（未招募）
1 期
Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITYArtritis Reumatoide_____________________________________Rheumatoid ArthritisMedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2009-016266-90-ESSanofi-aventis Recherche & Développement1,675
进行中（未招募）
1 期
Estudio aleatorizado , doble-ciego, controlado con placebo, multicéntrico, de fase III, para evaluar la terapia adyuvante con RAD001 frente a placebo, en pacientes con linfoma difuso de células grandes B (LDCGB) de elevado riesgo que hayan alcanzado una respuesta completa tras una primera línea de quimioterapia con rituximab.EUCTR2008-000498-40-ESovartis Farmacéutica S.A.915