FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095134 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study to compare safety and efficacy of Mirabegron with Tamsulosin versus Mirabegron with Silodosin in patients with Benign Prostatic Hyperplasia (BPH) 
Scientific Title of Study   A Multicenter, Randomized, Open-label, Parallel Group, Active Control, Phase III Study to Evaluate the Efficacy, Safety of Fixed Dose Combination of Mirabegron (ER) 25 mg/50 mg + Tamsulosin (MR) 0.4 mg/0.4 mg Tablets Versus Fixed Dose Combination of Mirabegron (ER) 25 mg and Silodosin 8mg Tablets in Adult Male Patients Diagnosed with Benign Prostatic Hyperplasia with Overactive Bladder with Lower Urinary Tract Symptoms 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MITAM/WBL/P3/2022 Version/ Date: 4.0/28 May 2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Antaryami Maharana  
Designation  GM medical affairs and Pharmacovigilance  
Affiliation  Abiogenesis Clinpharm Private Limited 
Address  2nd Floor, Plot No 69, D No. 8-2-248_1_7_69, Nagarjuna Hills,Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  7702186021  
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Antaryami Maharana  
Designation  GM medical affairs and Pharmacovigilance  
Affiliation  Abiogenesis Clinpharm Private Limited 
Address  2nd Floor, Plot No 69, D No. 8-2-248_1_7_69, Nagarjuna Hills,Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  7702186021  
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Public Query  
Name  Mr Prashant Dabral 
Designation  Head_Medico and Regulatory affairs 
Affiliation  M/s. Windlas Biotech Limited 
Address  40/1, Mohabewala industrial area

Dehradun
UTTARANCHAL
248110
India 
Phone  07906996184  
Fax  01356608199  
Email  Prashant@windlasbiotech.com  
 
Source of Monetary or Material Support  
M/s. Windlas Biotech Limited 40/1, Mohabewala Industrial Area, Dehradun – 248 110 Uttarakhand, India 
 
Primary Sponsor  
Name  M/s. Windlas Biotech Limited 
Address  40/1, Mohabewala Industrial Area, Dehradun – 248 110 Uttarakhand, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sambit Tripathy  AIIMS   Room number 42, 2nd floor Department of urology, room G 1, Bhubaneshwar, Odisha- 751019
Khordha
ORISSA 		 9810484410

sambit0tripathy@gmail.com 
Dr Amit Garg  Bhandari Hospital & Research Centre  Bhandari Hospital & Research Centre 138-A,room number 1, department of urology, Vasundhra Colony, Gopalpura Bypass, Tonk Road, Jaipur - 302018
Jaipur
RAJASTHAN 		 9179595900

bhrc.dramitgarg@gmail.com 
Dr Prem Mohan Jha  Gangasheel Advance Medical Research Institute  C-17 Deen Dayal Puram, Bareilly Uttar Pradesh – 243001
Bareilly
UTTAR PRADESH 		 9810400268

pmjha.nephro@gmail.com 
Dr Gourab Kundu  Medical college and Hospital   Department of Uro Surgery, Medical college and Hospital ,88 College Street, Kolkata 700073, West Bengal
Kolkata
WEST BENGAL 		 7381913926

drgourabkundu@gmail.com 
Dr G Appalaraju Amarapilli  Medigene multi Speciality Hospital Private Limited  Medigenemulti Speciality Hospital Private Limited (Akshaya Hospital) Is D.No.43-9-201, Sy No.321-323, Railway New Colony , Visakhapatnam, Andhra Pradesh, India - 530016
Visakhapatnam
ANDHRA PRADESH 		 9246666531

draappalaraju@gmail.com 
Dr Tapan Kumar Mandal  NRS Medical College and Hospital  Ground Floor, Department of Urology, NRS Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014, India
Kolkata
WEST BENGAL 		 9830367795

drtapankm25@gmail.com 
Dr Cornelius Jonnakuti  Nuha Hospitals  Room number 3, Department of Urology, Door No:12-19-61 and 62 Old Bank road, Kothapet, Guntur-522001, Andhra Pradesh,India
Guntur
ANDHRA PRADESH 		 80561 00278

jonnakutic@gmail.com 
Dr Makrand Manohar Joshi  Prakash Institute of Medical Sciences & Research  Prakash Institute of Medical Sciences & Research, room number 1, urology department, Urun-Islampur, Tal - Walwa, Sangli District, Maharashtra- 415 409
Sangli
MAHARASHTRA 		 7969792775

jmakrand288@gmail.com 
Dr Apoorva Jain  S.N Medical College   S.N Medical College, Room no 1 , first floor, Moti Katra Mantola Agra-282003, U.P - India AIIMS Bhubaneshwar, Odisha- 751019
Agra
UTTAR PRADESH 		 9760910218

apoorva7@hotmail.com 
Dr Anil Kumar Sanwal  Sanwal Hospital  Sanwal Hospital, Kanpur Road, Department or Urology,room number 1, Kanpur Road, Near Budelkhand University, Jhansi (U.P)-284128
Jhansi
UTTAR PRADESH 		 9415057206

aksanwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee  Submittted/Under Review 
Gangasheel Advanced Medical Research Institute  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics committee for Human Research Medical college and Hospital  Submittted/Under Review 
Institutional Ethics committee of Nuha Hospitals  Submittted/Under Review 
Institutional Ethics Committee S.N Medical College   Submittted/Under Review 
Nirmal hospital Institutional Ethics Committee  Submittted/Under Review 
Prakash Medical College Institutional Ethics Committee Prakash Institute of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC of Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tablet FDC of Mirabegron (ER) 50 mg and Tamsulosin (MR) 0.4 mg tablet  FDC Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tablet in group 1 may be up-titrated to the FDC Mirabegron (ER) 50 mg and Tamsulosin (MR) 0.4 mg tablet as per investigator discretion. 1 tablet per day for 12 weeks 
Comparator Agent  Fixed Dose Combination of Mirabegron (ER) 25 mg and Silodosin 8mg  Fixed Dose Combination of Mirabegron (ER) 25 mg and Silodosin 8mg one tablet per day for 12 weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1.Male participants aged 45 to 75 years (both inclusive) with confirmed clinical diagnosis of Benign Prostatic Hyperplasia (BPH) which is defined as having the following features:
(A)Moderate to severe lower urinary tract symptoms (LUTS) with International Prostate Symptom Score (IPSS) greater than 8 and
(B)maximum urinary flow rate less than 15 mL per s.
2.Participants with BPH complicated by overactive bladder with lower urinary tract symptoms (LUTS) (urinary frequency and urgency with or without incontinence) despite treatment with Silodosin 4 mg or other alpha blocker Tamsulosin 0.4 mg for more than equal to 4 weeks prior to screening.
3.Participant with number of micturition grater than or equal 8 times per 24 hours and at least 2 urgency episodes per 24 hours with or without incontinence in a 3day bladder diary during screening.
4.Participant with Post Void Residual volume less than equal to 150 ml and maximum urinary flow rate (Qmax) between 5 to 15 mL per s during screening.
5.Participant has Prostate Specific Antigen (PSA) less than4 ng per mL or greater than or equal 4 but less than 10 ng per mL with a prostate biopsy that is negative for cancer in the past 2 years.
6.Participants willing to give voluntarily their written informed consent to participate in the study before being screened for the study.
7.Able to adhere to study visit schedule and other protocol requirements.
8.Participants agrees not to participate in another trial while on treatment. 
 
ExclusionCriteria 
Details  1.Participant having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction.
2.Participant with clinically significant bladder outflow obstruction other than BPH (except large median lobe) due to calculi, tumor or stricture.
3.Participant having Urinary retention requiring catheterization.
4.Participant having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products.
5.Participants with Uncontrolled Diabetes having HbA1c value of greater than 8.0 percentage.
6.Participant taking Botulinum toxin injection for Urgency Urinary Incontinence (UUI) in the last year.
7.Current therapy with peripheral or sacral neuromodulation.
8.Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinsons disease).
9.Participants with significant cardiac disorder (e.g., cardiac valve disease requiring a specific treatment, pericardial constriction, Life-threatening arrhythmia, uncontrolled hypertension, Acute myocardial infarction, permanent atrial fibrillation).
10.Participants with severe renal insufficiency or ongoing or planned dialysis.
11.Participants with documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin greater than 3 x ULN accompanied by AST greater than ULN (assessed at screening) and or Child Pugh Class C.
12.Serum AST and/or ALT greater than 3 x ULN (assessed at screening).
13.Men who are unwilling to use contraception while receiving investigational product.
14.Known or suspected hypersensitivity to investigational products or any other component of the formulation.
15.Failure to control systemic fungal, bacterial or viral infection.
16.Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection.
17.Have a history of neurological or psychiatric disorders, including epilepsy or dementia.
18.According to the investigators judgment, there are concomitant diseases with a serious safety hazard or affect the participants participation in the study.
19.Using other experimental drugs or participating in other clinical trials in the prior one month.
20.Concomitant life-threatening disease with a life expectancy less than 12 months.
21.Any factor or condition likely to affect protocol compliance of the participant as judged by the investigator. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
Change in International Prostate Symptom Score (IPSS) score with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12 		 Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
Change in International Prostate Symptom Score (IPSS) score with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12 
 
Secondary Outcome  
Outcome  TimePoints 
•Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline(Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)).
•Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12
•Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 in the subgroup of participants with Incontinence categorised as OAB-wet
•Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12 		 baseline to 24 hours, 4 weeks, 8 weeks and 12 weeks  
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This is an randomized, open label, prospective, multi-center, three arms, active control study.
During Screening (Visit 1), participants who require treatment with Mirabegron and Tamsulosin will be assessed. Each participant will be given a diary card to record data for three consecutive days. The information collected from the diary card will be used to determine eligibility as per predefined criteria for the study. If participants meet all eligible criteria will be enrolled into the study. On day of Randomization (visit 2), Eligible 222 participants (74 per arm) will be randomized in a 1:1:1 ratio into one of the three groups. Participants will receive treatment orally once daily for 12 weeks either with the FDC of Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tablets or FDC of Mirabegron 50 mg and Tamsulosin (MR) 0.4 mg tablets of Windlas Biotech Limited or FDC of Mirabegron (ER) 25 mg and Silodosin 8mg Tablet.
 
Close