Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Fixed-dose combination of Alfuzosin 10 mg ER plus Tadalafil 2.5 mg Tablets: The recommended dosage is
one tablet of FDC of Alfuzosin 10 mg ER plus Tadalafil 2.5 mg Tablets oforally once
Sponsors
Akums Drugs Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men aged 45 or older. 2. Clinical signs and symptoms of BPH for >=6 months. 3. Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) >13. 4. An IPSS QoL score of >3 at screening. 5. Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening.
Exclusion criteria
Exclusion criteria: 1. Stone in the bladder or urethra causing symptoms. 2. Acute or chronic prostatitis. 3. Documented history of Interstitial cystitis/painful bladder syndrome. 4. Patients who had failed treatment with finasteride. 5. Patients with Prostate Specific Antigen (PSA) beyond 4 ng/ml at screening. 6. Hypersensitivity towards any component of the investigational medicinal product (IMP). 7. Patients previously not improved by an alpha1-blocker treatment. 8. Acute or recurrent urinary tract infections. 9. Patients with history of prostate cancer. 10. History of acute urinary retention (AUR). 11. History of any of the following pelvic conditions: • Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery. • Pelvic radiotherapy. • Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies. • Lower tract malignancy or trauma. 12. Clinically significant microscopic haematuria at screening. 13. Any causes other than BPH, which may affect the evaluation of symptoms of urine flow (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator. 14. Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patients health, or the outcome of the trial as judged by the Investigator. 15. Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin. 16. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 17. Mental incapacity or language barrier precluding adequate understanding or co-operation. 18. History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening. 19. Previous participation in any Alfuzosin and tadalafil or any relevant clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit.Timepoint: Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in IPSS postmicturition subscore (Question 1 of IPSS) from baseline to each visit.Timepoint: Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2);Mean change in IPSS QoL Index Score at the end of study visit compared to baseline visit.Timepoint: Baseline (Day 0), Visit 5 (Day 84±2);Mean Change in IPSS storage subscore (Question 2, 4, 7 of IPSS) from baseline to each visit.Timepoint: Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2);Mean Change in IPSS Voiding subscore (Question 3, 5, 6 of IPSS) from baseline to each visit.Timepoint: Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2);Mean Change in Maximum Urinary Flow Rate (Qmax) at the end of study visit compared to baseline visit.Timepoint: Baseline (Day 0), Visit 5 (Day 84±2);Mean change in urine flow rate (Qmean) at the end of study visit compared to baseline visit.Timepoint: Baseline (Day 0), Visit 5 (Day 84±2) | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed