A Phase III, Multi-Centre, Double-Blind, Randomised, Parallel-Group, Active-Controlled Trial to compare Efficacy and Safety of Fixed Dose Combination of Alfuzosin 10 mg/10 mg ER plus Tadalafil 2.5 mg/5 mg Tablets versus Alfuzosin 10 mg ER Tablets in Patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 12
- 主要终点
- Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit.
研究概览
简要总结
This is a randomized, double blind, multicentre, active controlled, comparative, parallel group, phase III clinical study in patient with lower urinary tract symptoms (LUTS) associated with benign prostatic
hyperplasia (BPH) in Indian population.
Laboratory assessments (Haematology and Biochemistry) shall be performed on screening and end of study visit.
Patients will be provided with subject diary to record details about study drug administration, rescue medication, and adverse events. Patients will be required to bring completed diary at each visit. At randomization/baseline visit, subjects shall be randomly (Double blind) assigned in 1:1:1 fashion to one of the three treatment groups for 12 weeks. Those subjects who do not meet
the inclusion/exclusion criteria will be considered as screen failures. The randomized subjects will be provided with study medication and asked to follow up for further visits till 12 weeks post randomization.
Patients will be instructed to administer one tablet of test products or comparator product orally once daily, in the morning after breakfast for 12 weeks of treatment duration.
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study.
Following are the Study Visit Details:
• Visit 1: Screening Visit (Days -7 to Day -1)
• Visit 2: Randomization/Baseline Visit (Day 0)
• Visit 3: Follow-up Visit (Week 4/Day 28 ± 2 days)
• Visit 4: Follow-up Visit (Week 8/Day 56 ± 2 days)
• Visit 5: End of Study/Early Discontinuation Visit (Week 12/Day 84 ± 2 days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •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) >
- •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.
排除标准
- •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.
- •â€¢Pelvic radiotherapy.
- •â€¢Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies.
- •â€¢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.
结局指标
主要结局
Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit.
时间窗: Mean Change in Total International Prostate Symptom Score (IPSS) from baseline to each visit.
次要结局
- Mean Change in IPSS Voiding subscore (Question 3, 5, 6 of IPSS) from baseline to each visit.(Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2))
- Mean Change in IPSS storage subscore (Question 2, 4, 7 of IPSS) from baseline to each visit.(Baseline (Day 0), Visit 3 (Day 28±2), Visit 4 (Day 56±2), Visit 5 (Day 84±2))
- Mean Change in IPSS postmicturition subscore (Question 1 of IPSS) from baseline to each visit.(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.(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.(Baseline (Day 0), Visit 5 (Day 84±2))
- Mean change in IPSS QoL Index Score at the end of study visit compared to baseline visit.(Baseline (Day 0), Visit 5 (Day 84±2))