An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, 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
- 1,067
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
详细描述
This is an open-label extension study following the double blind 905-CL-055 study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completion of 12 weeks double-blind treatment in Study 905-CL-055
排除标准
- •Any significant PVR volume (>150 mL)
研究组 & 干预措施
Total Group
Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
干预措施: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) (Drug)
Total Group
Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
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
Number of Participants With Adverse Events (AEs)
时间窗: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
时间窗: Baseline and up to 52 weeks of FDC treatment
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
时间窗: Baseline and up to 52 weeks of FDC treatment
Qmax during a micturition (urination) was recorded using uroflowmetry.
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
时间窗: Baseline and up to 52 weeks of FDC treatment
Qmean during a micturition (urination) was recorded using uroflowmetry.
Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
时间窗: Baseline and up to 52 weeks of FDC treatment
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 up to 52 weeks of FDC treatment
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 TUS/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 up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in IPSS Voiding Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in IPSS Storage Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Individual IPSS Scores(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Symptom Bother Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score(Baseline and up to 52 weeks of FDC treatment)
- Number of OAB-q Responders Based on Health-related Quality of Life: Total Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Mobility Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Self-care Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Usual Activities Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score(Baseline and up to 52 weeks of FDC treatment)
- Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score(Baseline and up to 52 weeks of FDC treatment)