A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,334
- 主要终点
- Change From Baseline to End of Treatment in Total International Prostate Symptom Score
研究概览
简要总结
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
- •A total International Prostate Symptom Score (IPSS) of ≥13
- •A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
- •A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)
排除标准
- •Any significant Post Void Residual volume (>150 mL)
- •A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
- •Evidence of a symptomatic urinary tract infection
研究组 & 干预措施
Placebo
Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo tamsulosin hydrochloride OCAS 0.4 mg (Drug)
Placebo
Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg (Drug)
Placebo
Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Drug)
TOCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg (Drug)
TOCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Drug)
TOCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: tamsulosin hydrochloride OCAS 0.4 mg (Drug)
FDC 0.4 mg/6 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo tamsulosin hydrochloride OCAS 0.4 mg (Drug)
FDC 0.4 mg/6 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Drug)
FDC 0.4 mg/6 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) (Drug)
FDC 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo tamsulosin hydrochloride OCAS 0.4 mg (Drug)
FDC 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg (Drug)
FDC 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
干预措施: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in Total International Prostate Symptom Score
时间窗: Baseline and Week 12
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
时间窗: Baseline and Week 12
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: - 0. No urgency; - 1. Mild urgency; - 2. Moderate urgency; - 3. Severe urgency; - 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
次要结局
- Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition(Baseline and Week 12)
- Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours(Baseline and Week 12)
- Change From Baseline to End of Treatment in IPSS Voiding Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in IPSS Storage Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in IPSS QoL Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in Individual IPSS Scores(Baseline and Week 12)
- Change From Baseline to End of Treatment in Symptom Bother Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in HRQoL Subscale: Social Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in HRQoL Subscale: Total Score(Baseline and Week 12)
- Percentage of Participants Who Were OAB-q Responders at End of Treatment(Week 12 (end of treatment))
- Change From Baseline to End of Treatment in EQ-5D Mobility Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in EQ-5D Self-care Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in EQ-5D Usual Activities Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score(Baseline and Week 12)
- Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score(Baseline and Week 12)
- Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms(Baseline and Week 12)
- Patient Global Impression Scale at End of Treatment: General Health(Baseline and Week 12)
- Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms(Baseline and Week 12)
- Number of Participants With Adverse Events (AEs)(From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks))
- Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume(Baseline and Week 12)
- Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)(Baseline and Week 12)
- Change From Baseline to End of Treatment in Average Flow Rate (Qmean)(Baseline and Week 12)
- Apparent Clearance (CL/F) of Tamsulosin(Week 4, Week 8 and Week 12)
- Maximum Concentration at Steady State (Cmaxss) of Tamsulosin(Week 4, Week 8 and Week 12)
- Minimum Concentration at Steady State (Cminss) of Tamsulosin(Week 4, Week 8 and Week 12)
- Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin(Week 4, Week 8 and Week 12)
- Area Under the Curve at Steady State (AUCss) of Tamsulosin(Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose))
- CL/F of Solifenacin(Week 4, Week 8 and Week 12)
- Cmaxss of Solifenacin(Week 4, Week 8 and Week 12)
- Cminss of Solifenacin(Week 4, Week 8 and Week 12)
- Tmaxss of Solifenacin(Week 4, Week 8 and Week 12)
- AUCss of Solifenacin(Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose))