A study to evaluate the safety and efficacy of fixed dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia.

Phase 4

Completed

• Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2021/09/036299
• Lead Sponsor: Akums Drugs Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Male subjects of age 45 or above with current diagnosis of benign prostatic hyperplasia.

2. International prostate symptom score (IPSS) at presentation > 7.

3. Able to provide written informed consent and to comply with all study procedures.

Exclusion Criteria

1. History of clinically significant (as determined by the investigator) cardiac,

endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,

immunologic disease, or other major uncontrolled disease.

2. Patients with Prostate-Specific Antigen (PSA) level > 4.0ng/mL

3. History of allergy to any component of the IP.

4. Patients with a residual urinary volume of �250 ml.

5. Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)].

6. Patients with severe hepatic impairment.

7. Subjects taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole,

clarithromycin, itraconazole, ritonavir).

8. Hypersensitivity to �±1A-receptor blockers and 5 alpha-reductase inhibitors.

9. Presence of a condition or abnormality that in the opinion of the investigator would

compromise the safety of the patient or the quality of the data.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in International Prostate Symptom Score (IPSS). <br/ ><br> <br/ ><br>2. Mean change in Peak Urine Flow Rate (Qmax).Timepoint: 1. Day-7 to -1 (Visit 1), Day 28�±2 ( visit 3), Day 56�±2 (visit 4), Day 84�±2 (Visit 5) <br/ ><br> <br/ ><br>2. Day 01 (Visit 2) and Day 84�±2 (Visit 5)

Secondary Outcome Measures

Name	Time	Method
1. Change from baseline in Quality of Life (QOL) due to urinary symptoms. <br/ ><br> <br/ ><br>2. Percentage of treatment responders achieving decrease in IPSS score from baseline <br/ ><br>of â�¥25%.Timepoint: 1. Day-7 to -1 (Visit 1), Day 28�±2 ( visit 3), Day 56�±2 (visit 4), Day 84�±2 (Visit 5). <br/ ><br>