CTRI/2021/12/038380已完成3 期
A Randomized, Multi-Centric, Double-Blind, Double-Dummy, Parallel, Active Controlled Study to Evaluate Efficacy and Safety of Fixed Dose Combination of Silodosin and Tadalafil Capsules in Comparison to Tadalafil Tablets for the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia and Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Male patient, aged 50 to 75 years (both inclusive)
- •2)Patient who is already on alpha (a)-blockers for BPH OR Phosphodiesterase 5 inhibitors (PDE5Is) for BPH and ED
- •3)Patient having total International Prostate Symptom Score (IPSS) score = 13
- •4)Patient with maximum urinary flow rate (Qmax) of 4 to 15 mL/second (both inclusive) and minimum voided volume = 125 mL at the time of randomization
- •5)Patient with Post-void residual (PVR) volume < 300 mL as assessed by ultrasound at the time of randomization
- •6)Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of = 25 at the time of randomization
- •7)Patient is willing to give informed consent, able to swallow study medications and follow study protocol.
排除标准
- •1)Patient with prostate specific antigen (PSA) = 4 ng/mL at screening and randomization.
- •2)Patient with history of neurologic bladder, urethral strictures, urinary tract infections, urologic cancer, and prostatic surgery
- •3)Patient with clinically significant bladder outflow obstruction other than BPH (calculi, tumor or stricture), as judged by Investigator
- •4)Patient undergoing haemodialysis
- •5)Patient with moderate to severe renal impairment (Creatinine clearance < 50 mL/min) and hepatic impairment (Aspartate Aminotransferase [AST] and Alanine Transaminase [ALT] ? 3 x upper limit of normal [ULN])
- •6)Clinical evidence of any other active bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening.
- •7)Current or past history of symptomatic orthostatic hypotension or recurrent dizziness, vertigo, loss of consciousness or syncope.
- •8)Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components.
- •9)Patient with blood pressure (BP) = 140/90 mm of Hg or Glycosylated hemoglobin (HbA1c) ? 9%.
- •10)Patient has a clinically significant disorder that (for ex. Patient who is likely to require catheterization within next 3 months, unable to take oral medications), in the opinion of the investigator, would result in the patient’s inability to understand and comply with the requirements of the study
- •11)Patient with history of Human immunodeficiency virus (HIV) and/or Hepatitis B and/or Hepatitis C.
- •12)Patient planning cataract surgery during the study
- •13)Use of any 5-a-reductase inhibitor, any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), or other drugs which affect prostate volume, within past 3 months prior to screening.
- •14)Patient on nitrates or beta-agonists within 2 weeks of screening or who are planning to take during the study
- •15)Patient using strong Cytochrome P4503A4 (CYP4503A4) inhibitors (ketoconazole, clarithromycin, itraconazole, ritonavir etc.), strong P-glycoprotein (P-gp) Inhibitors (for e.g. Ketoconazole) at the time of screening or during study
- •16)Patient with known alcohol or other substance abuse within last one year as per The Diagnostic and Statistical Manual of Mental Disorders (DSM) – 5 criteria
- •17)Patient involved in professions like driving, operating heavy machinery or performing hazardous work
- •18)Patient who have participated in another investigational study within 3 months prior to enrolment in this study
研究者
相似试验
尚未招募
3 期
A clinical study to see the effect and safety of Fixed Dose Combination of Silodosin and Solifenacin Capsules in Comparison to Silodosin Capsules in Male Patients Having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) with Over Active Bladder (OAB)CTRI/2020/07/026419Sun Pharma Laboratories Limited
进行中（未招募）
1 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel group, Dose Response Study of subcutaneous AVE5026 with an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery - TREKPatients undergoing elective total knee replacement surgery (risk of venous thromboembolic event)MedDRA version: 8.1Level: LLTClassification code 10049909EUCTR2005-006202-26-NOSanofi-Aventis Recherche et Développement800
已完成
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled,<br>Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens<br>(Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the<br>Prevention of Chronic Cluster HeadacheCluster HeadacheNL-OMON45623TEVA Pharma20
进行中（未招募）
1 期
This is a Phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18 – 75 years of age) with moderate to severe AD who are candidates for systemic therapy. The study is comprised of a 35-day Screening Period, a 24-week blinded treatment period, and a 12-week Follow-up period.moderate to severe Atopic DermatitisMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2018-002264-57-ESAbbVie Deutschland GmbH & Co. KG692
撤回
3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled,<br>Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens<br>(Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the<br>Prevention of Episodic Cluster HeadacheCluster HeadacheNL-OMON47278TEVA Pharma20