Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms
Conditions
Interventions
Intervention1: Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules: Fixed Dose Combination of Tamsulosin Hydrochloride Prolonged Release and Tadalafil Capsules
One capsule once daily sho
Sponsors
Sun Pharma Laboratory Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 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 6) Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of 7) Patient is willing to give informed consent, able to swallow study medications and follow study protocol.
Exclusion criteria
Exclusion criteria: 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 =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 α1-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 17) Patient with history of HIV and / or Hepatitis B and/ or Hepatitis C 18) Patient with history of bleeding disorders or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 1. Proportion of participants with treatment-emergent adverse events (TEAEs) Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1. Change in Total International Prostate Symptom Score (IPSS) from baseline [Time frame: 4, 8 and 12 weeks] 2. Change in IPSS storage (Irritative) sub score from baseline [Time frame: 4, 8 and 12 weeks] 3. Change in IPSS voiding (Obstructive) sub score from baseline [Time frame: 4, 8 and 12 weeks] 4. Change in IPSS Quality of Life (QoL) Index from baseline [Time frame: 12 weeks] 5. Change in Qmax from baseline[Time frame: 4, 8 and 12 weeks] 6. Change in PVR volume from baseline [Time frame: 4, 8 and 12 weeks] 7. Change in IIEF-EF (questions 1â??5 and 15) score from baseline [Time frame: 4, 8 and 12 weeks] 8. Proportion of patients showing normal erectile function (IIEF-EF score 26) at the end of 12 weeks [Time Frame: Week 12] Timepoint: 04 Weeks, 08 Weeks and 12 Weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed