EUCTR2008-000536-40-ES进行中（未招募）1 期
Ensayo pivotal de fase III para determinar la eficacia y la seguridad del comprimido bucodispersable de vardenafilo comparado con placebo en el tratamiento de hombres con disfunción eréctil (DE) – ensayo multicéntrico, aleatorizado, doble ciego y de dosis fija – POTENT I Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I - POTENT I
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
- •1)Males 18 years-of-age or older.
- •2)Stable, heterosexual relationship for at least 6 months.
- •3)A history of erectile dysfunction (ED) for at least 6 months, defined as the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse” by the NIH Consensus Development Panel on Impotence.1
- •4)The subject must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Subject Diary: Was sexual activity initiated with the intention of intercourse?”) (to be fulfilled at visit 2).
- •5)At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful, according to the following questions from the Subject Diary (at least one question should be answered with a No”): a)Were you able to achieve at least some erection (some enlargement of the penis)?” b)Were you able to insert your penis in your partner’s vagina?” c)”Did your erection last long enough for you to have successful intercourse?” (to be fulfilled at visit 2).
- •6)Subjects highly motivated to obtain treatment for erectile dysfunction.
- •7)Documented, dated, written informed consent.
- •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)Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report.1
- •2)History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 (= screening).
- •3)Uncontrolled atrial fibrillation / flutter at screening (defined as ventricular response rate = 100 bpm).
- •4)Bleeding disorder.
- •5)History of surgical prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of benign prostate hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation.
- •6)Hereditary degenerative retinal disorders such as retinitis pigmentosa.
- •7)History of loss of vision because of NAION, temporary or permanent loss of vision, including unilateral loss of vision.
- •8)Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) which, in the investigator’s opinion, would significantly impair sexual performance.
- •9)Subjects who have been confirmed with phenylketonuria (PKU).
- •10)Primary hypoactive sexual desire.
- •11)Spinal cord injury.
- •12)Severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment.
- •13)Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma, and leukemia.
- •14)Active peptic ulceration.
- •15)Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
- •16)History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
- •17)History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
- •18)Symptomatic postural hypotension within 6 months of Visit 1.
- •19)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.
- •20) History of congenital QT prolongation.
- •4.2.2.2Concomitant medication
- •1)Subjects who are taking nitrates or nitric oxide donors.
- •2)Subjects who are exposed to androgens irrespective of their mode of administration.
- •3)Subjects who are taking anti-androgens. Clarification: 5alpha-reductase inhibitors, commonly not classified as anti-androgens, are permitted.
- •4)Subjects who are taking alpha-blockers.
- •5)Subjects who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole or ketoconazole (topical forms are allowed), and the macrolide antibiotics clarithromycin and erythromycin.
- •6)Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
- •7)Use of any treatment for ED within 7 days of Visit 1 or during the study including oral medications, vacuu
研究者
相似试验
进行中（未招募）
1 期
Ensayo de fase III para evaluar la función de letrozol continuo vs. letrozol intermitente tras 4 a 6 años de terapia endocrina adyuvante previa en mujeres posmenopáusicas con cáncer de mama temprano con receptores hormonales positivos y ganglios positivos. - SOLEEUCTR2007-001370-88-ESInternational Breast Cancer Study Group (IBCSG)4,800
进行中（未招募）
1 期
Estudio de fase III para evaluar la eficacia y la seguridad de docetaxel y prednisona con o sin lenalidomida en pacientes con cáncer de próstata resistente a la castración (CPRC).A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DOCETAXEL AND PREDNISONE WITH OR WITHOUT LENALIDOMIDE IN SUBJECTS WITH CASTRATE-RESISTANT PROSTATE CANCERPacientes con cáncer de próstata metastásico sin experiencia de quimioterapia y con elevación documentada del antígeno prostático específico (PSA) o enfermedad progresiva (EP) documentada después de tratamiento hormonal.Chemo-naïve metastatic prostate cancer subjects with documented rising Prostate Specific Antigen (PSA) or documented Progressive Disease (PD) following hormonal therapyMedDRA version: 12.0Level: PTClassification code 10036909Term: Prostate cancer metastaticEUCTR2008-007969-23-ESCelgene Corporation1,015
进行中（未招募）
1 期
First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole.Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis.MedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-005409-38-ESFundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)56
进行中（未招募）
1 期
Investigating a Vaccine Against COVID-19SARS-CoV-2MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001228-32-GBCTRG12,390
进行中（未招募）
1 期
Ensayo clínico, fase III, para conocer la seguridad y eficacia de Sativex® para el alivio sintomático de la espasticidad en sujetos con esclerosis múltiple (Fase A Simple ciego para conocer la respuesta, y fase B, doble ciego, aleatorizado, con grupos paralelos controlado con placeboEspasticidad en esclerosis múltipleEUCTR2006-005910-11-ESGW Pharma Ltd.356