A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Fixed Dose Combination of Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction.

Sun Pharma Laboratory Limited SP0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

阶段: 4 期
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

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) Sexually active male patient, aged between 45 to 75 years (both inclusive), diagnosed with BPH and Erectile dysfunction
•2) Patient who is taking both Tamsulosin 0.4 mg and Tadalafil 5 mg concomitantly for BPH and ED at Screening [Note: Patients will undergo a wash out period of 28 days)
•3) Patient having total International Prostate Symptom Score (IPSS) score >= 8 (moderate to severe BPH) at the time of enrolment
•4) Patient having Qmax between 5 ml/sec and 15 ml/sec (both included) with minimum voided volume of >125 ml at the time of enrolment
•5) Patient with PVR volume < 300 mL as assessed by ultrasound at enrolment
•6) Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of <= 25 at the time of enrolment
•7) Patient is willing to give informed consent, able to swallow study medications and follow study protocol.

排除标准

•1) Prostate specific antigen (PSA) beyond 4 ng/mL at screening, and enrolment
•2) Patient with history of neurologic bladder, urethral strictures, urinary tract infections, prostatitis, 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) Clinical evidence of any other bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening
•5) Patient undergoing haemodialysis
•6) Patient who are planning for cataract or glaucoma surgery
•7) Patients with history of cardiovascular disease (including but not limited to):
•- History of myocardial infarction within the last 90 days
•- History of angina
•- History of Congestive cardiac failure (New York Heart Association Class 2 or higher) in the last 6 months
•- Patients with uncontrolled arrhythmias, hypotension (BP <90/60 mm Hg) or uncontrolled hypertension (>=170/100 mmHg)
•- History of orthostatic hypotension, or recurrent dizziness, vertigo, loss of consciousness or syncope
•- History of stroke within the last 6 months
•Known left ventricular outflow tract obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic valve stenosis)
•- Patients with any other cardiac disease for which sexual activity is not recommended
•8) Patient with any other clinically significant disorder that (for e.g. 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 patientâ??s inability to understand and comply with the requirements of the study
•9) Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronies disease)
•10) Patients history of priapism with prior use of Î±1-blocker(s)/PDE-5 inhibitors (or combination of both), or have known condition(s) which may predispose them to priapism (e.g. Sickle cell anemia) as per Investigatorâ??s discretion
•11) Patient with history of hereditary degenerative retinal disorders (e.g., retinitis pigmentosa) or ischemic optic neuropathy including non-arteritic anterior ischemic optic neuropathy (NAION)
•12) Use of any 5-alpha reductase inhibitor, androgens, anti-androgens, any drugs with androgenic or anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, metronidazole, progestational agents), anabolic steroids, LHRH agonists/antagonists or other drugs which affect prostate volume, within past 3 months of the screening visit
•13) Patient on nitrates or beta-agonists within 2 weeks of screening or who are planning to take during the study
•14) Patient using strong inhibitors of CYP3A4 (e.g. ketoconazole, ritonavir, itraconazole), moderate inhibitors of CYP3A4 (e.g. erythromycin), strong or moderate inhibitors of CYP2D6 (e.g. paroxetine, terbinafine), CYP3A4 inducers (e.g. rifampin), GC stimulator (e.g. riociguat) at screening
•15) Patients with glycosylated hemoglobin (HbA1c) >= 7.5 % at screening
•16) Patient with moderate to severe renal impairment (Creatinine clearance < 50 mL/min) and hepatic impairment (AST and ALT Ë? 3 x ULN)
•17) Patient with history of HIV and / or Hepatitis B and/ or Hepatitis C
•18) Patient with history of bleeding disorders or

研究者

发起方

Sun Pharma Laboratory Limited SP

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