EUCTR2004-002172-42-ES进行中（未招募）1 期
Estudio aleatorizado, doble ciego, enmascarado, multicéntrico, controlado con placebo, de grupos paralelos para comparar la seguridad y la eficacia de vardenafilo tomado una vez al día frente al tratamiento a libre demanda para mejorar la función eréctil en varones inmediatamente después de haber sido sometidos a una prostatectomía radical con preservación nerviosa bilateral. - REINVENT (Recovery of Erection: Intervention with Vardenafil Early Nightly Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •At Screening:
- •Males 18-64 years of age
- •Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator’s usual clinical practice
- •Surgery scheduled within about 1 month of screening (Visit 1)
- •Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
- •Heterosexual relationship.
- •No pre-operative erectile dysfunction: International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening (Visit 1) without any therapy/devices for improvement of erections. No previous use of any therapy/devices for erectile dysfunction
- •Historical total prostate specific antigen (PSA) <10 ng/mL
- •Gleason Tumor Score = 7 on biopsy
- •No perforation of the prostate capsule by tumor: Clinical stage pre-operatively T1c to T2c
- •Documented, signed and dated written Informed Consent
- •At Randomization:
- •Bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
- •BNSRRP occurred within approximately 1 month post screening (Visit 1)
- •No perforation of the prostate capsule by tumor: No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At Screening:
- •A)Previous or Current Medical Conditions:
- •Any unstable medical, psychiatric, or substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study
- •Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance
- •Primary hypoactive sexual desire
- •Spinal cord injury
- •Hereditary degenerative retinal disorders such as retinitis pigmentosa
- •History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
- •Severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- •Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
- •Bleeding disorder
- •Significant active peptic ulceration
- •Any underlying cardiovascular condition (such as unstable angina pectoris or severe heart failure New York Heart Association class III or IV) including unstable angina pectoris that would preclude sexual activity
- •History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
- •Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm)
- •Resting hypotension (a resting systolic blood pressure of <90 mm Hg or diastolic blood pressure <50 mmg Hg) or hypertension (a resting systolic blood pressure >170 mm Hg or a resting diastolic blood pressure >110 mm Hg)
- •Symptomatic postural hypotension within 6 months of Visit 1
- •History of malignancy within the past 5 years (other than prostate cancer or squamous or basal cell skin cancer)
- •Life expectancy <3 years
- •Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h).
- •Diabetes mellitus: type I, type II with presence of end organ symptomatology (e.g. peripheral neuropathy, nephropathy, retinopathy, amyotrophy)
- •B) Concomitant Medication:
- •Nitrates or nitric oxide donors
- •Oral or injectable androgens
- •Anti-androgens
- •Any of the following potent inhibitors of cytochrome P- 450 3A4: HIV protease inhibitors such as ritonavir or indinavir; anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed); or erythromycin
- •Any investigational drug (including placebo) within 30 days of Visit 1
- •Any treatment for ED historically or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
- •Alpha blockers (unless they can be discontinued by one week before randomisation)
- •5-alpha-reductase inhibitors
- •C) Abnormal Laboratory Values:
- •Serum total testosterone level >25% below the lower limit of normal (according to the range of the testing laboratory).
- •Serum creatinine > 3.0 mg/dL.
- •Elevation of AST and/or ALT >3X the ULN
- •D) Other Excl
研究者
相似试验
进行中（未招募）
1 期
?Estudio aleatorizado, con doble enmascaramiento, controlado con placebo y de grupos paralelos de la eficacia y la seguridad de dos dosis de comprimidos para chupar de lisinato de ketoprofeno (6,25 mg y 12,5 mg) en pacientes con dolor de garganta? - KRYSTAEUCTR2008-008265-36-ESSANOFI-AVENTIS GROUPE835
进行中（未招募）
1 期
Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).EUCTR2005-003694-25-ESF. Hoffmann-La Roche Ltd200
进行中（未招募）
1 期
Estudio aleatorizado, doble ciego, de dos brazos, controlado con placebo y de 12 meses de duración de los efectos de rimonabant 20 mg una vez al día sobre la cantidad y actividad de la grasa visceral en pacientes con obesidad abdominal y síndrome metabólico. A randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20 mg once daily on the amount and the activity of visceral fat in abdominally obese patients with metabolic syndrome. - VICTORIAPacientes con obesidad abdominal con síndrome metabólico.MedDRA version: 8.0Level: LLTClassification code 10029883EUCTR2005-002568-27-ESSanofi-Synthelabo Groupe230
进行中（未招募）
1 期
Estudio aleatorizado, doble ciego, en el que se comparan los efectos de un régimen de clopidogrel durante 3 meses en combinación con AAS durante el primer mes, frente a AAS en monoterapia, para el tratamiento agudo de pacientes con AIT o ictus menor.Randomized, double-blind trial comparing the effects of a 3-month clopidogrel regimen, combined with ASA during the first month, versus ASA alone for the acute treatment of patients with TIA or minor stroke - CASTIAEl tratamiento agudo de pacientes con AIT o ictus menor.The acute treatment of patients with TIA or minor strokeMedDRA version: 8.1Level: HLTClassification code 10008192EUCTR2005-005763-28-ESSanofi-Aventis Groupe2,400
进行中（未招募）
不适用
Estudio aleatorizado y en doble ciego, dirigido a evaluar la eficacia y la seguridad de etanercept 50 mg dos veces a la semana y etanercept 50 mg una vez a la semana en el tratamiento de la psoriasis de grado moderado a severoA Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe PsoriasisPsoriasis en placa de grado moderado a severoModerate to severe plaque psoriasisEUCTR2007-001724-12-ESWyeth Pharmaceuticals France250