A study to compare effect and safety of combination of Alfuzosin hydrochloride extended release and Tadalafil in comparison to Alfuzosin hydrochloride extended release in patients having Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms in India
- Conditions
- Health Condition 1: null- Benign Prostatic Hyperplasia (BPH) and Lower urinary tract symptoms (LUTS)Health Condition 2: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2017/08/009487
- Lead Sponsor
- Sun Pharma Laboratories Limited SP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 420
1.Male patients, aged 45 to 75 years, diagnosed with benign prostatic hyperplasia (BPH) and LUTS. (New or old taking alpha blockers for BPH)
2.Patients having IPSS score greater than 8 (moderate to severe BPH) at the time of screening.
3.Patient or his legally accepted representative is willing to give informed consent.
1.Use of any 5-alpha-reductase inhibitor, any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit
2.ED therapy (er. PDE5 inhibitors), OAB for at least 4 weeks prior to Randomization.
3.Prostate specific antigen (PSA) beyond 4 ng/mL at screening.
4.History of urinary retention or lower urinary tract (bladder) stone within 6 months of screening
5.History of urethral obstruction due to stricture, valves, sclerosis or tumor at screening.
6.Clinical evidence of prostate cancer or prostatitis at screening.
7.Clinical evidence of any other bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening
8.Current or recent substance abuse, including alcohol.
9.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
10.History of severe cardiac conditions, including Angina requiring certain treatment with nitrates
11.History of symptomatic orthostatic hypotension or recurrent dizziness, vertigo, loss of consciousness or syncope.
12.History of significant central nervous system disease (including stroke or spinal cord injury within 6 months of screening)
13.Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists or anabolic steroids at initiation (at screening)
14.Patients having hypersensitivity or any other contraindication to any of the Investigational products including its components.
15.Medical history or clinical evidence of any pelvic, as judged by the urologist, might compromise protocol compliance
16.Glycosylated hemoglobin (HbA1c) greater than 9% at screening.
17.Patients judged unfit for this study (e.g. moderate to severe hepatic impairment) by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in Total International Prostate Symptom Score (IPSS) from baselineTimepoint: [Time frame:12 weeks]
- Secondary Outcome Measures
Name Time Method 1.Change in IPSS storage(Irritative)subscore from baseline <br/ ><br>2.Change in IPSS voiding(Obstructive)subscore from baseline <br/ ><br>3.Change in Total International Prostate Symptom Score from baseline <br/ ><br>4.PGI-I <br/ ><br>5.Change in uroflowmetry measures[(Peak Urine Flow Rate(Qmax),Mean Urine Flow Rate(Qmean)and Voided Volume(Vcomp)] <br/ ><br>6.CGI-I <br/ ><br>7.Change in IPSS QoL Index <br/ ><br>Secondary Safety Outcome measure: <br/ ><br>1.Proportion of participants with adverse events and serious adverse eventsTimepoint: 1.[Time frame:baseline,4,8 and 12 weeks] <br/ ><br>2.[Time frame:4,8 and 12 weeks] <br/ ><br>3.[Time frame:4 and 8 weeks] <br/ ><br>4.[Time frame:12 weeks] <br/ ><br>5.[Time frame:baseline,4,8 and 12 weeks] <br/ ><br>6.[Time frame:12 weeks] <br/ ><br>7.[Time frame:baseline,12 weeks] <br/ ><br>Secondary Safety Outcome measure: <br/ ><br>1.[Time frame:12 weeks]