跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01972841
NCT01972841已完成3 期

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Astellas Pharma Europe B.V.435 个研究点 分布在 1 个国家目标入组 3,527 人开始时间: 2013年11月5日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,527
试验地点
435
主要终点
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
  • •Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

排除标准

  • •Subject had significant PVR volume (> 150 mL);
  • •Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
  • •Subject had an indwelling catheter or practices intermittent self catheterization.
  • •Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
  • •Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
  • •Subject had moderate to severe hepatic impairment
  • •Subject had severe renal impairment
  • •Subject had a clinically significant abnormal ECG
  • •Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
  • •Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
  • •Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

研究组 & 干预措施

1: Solifenacin 5 mg + Mirabegron 25 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

干预措施: Mirabegron (Drug)

3: Placebo

Placebo Comparator

Participants who received matching placebo once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

4: Solifenacin 5 mg

Active Comparator

Participants who received solifenacin 5 mg once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

6: Mirabegron 50 mg

Active Comparator

Participants who received mirabegron 50 mg once a day for 12 weeks.

干预措施: Mirabegron (Drug)

6: Mirabegron 50 mg

Active Comparator

Participants who received mirabegron 50 mg once a day for 12 weeks.

干预措施: Placebo to match solifenacin succinate (Drug)

6: Mirabegron 50 mg

Active Comparator

Participants who received mirabegron 50 mg once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

2: Solifenacin 5 mg + Mirabegron 50 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

1: Solifenacin 5 mg + Mirabegron 25 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

干预措施: Solifenacin succinate (Drug)

4: Solifenacin 5 mg

Active Comparator

Participants who received solifenacin 5 mg once a day for 12 weeks.

干预措施: Solifenacin succinate (Drug)

5:Mirabegron 25 mg

Active Comparator

Participants who received mirabegron 25 mg once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

5:Mirabegron 25 mg

Active Comparator

Participants who received mirabegron 25 mg once a day for 12 weeks.

干预措施: Placebo to match solifenacin succinate (Drug)

5:Mirabegron 25 mg

Active Comparator

Participants who received mirabegron 25 mg once a day for 12 weeks.

干预措施: Mirabegron (Drug)

3: Placebo

Placebo Comparator

Participants who received matching placebo once a day for 12 weeks.

干预措施: Placebo to match solifenacin succinate (Drug)

2: Solifenacin 5 mg + Mirabegron 50 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

干预措施: Mirabegron (Drug)

2: Solifenacin 5 mg + Mirabegron 50 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.

干预措施: Solifenacin succinate (Drug)

1: Solifenacin 5 mg + Mirabegron 25 mg

Experimental

Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.

干预措施: Placebo to match mirabegron (Drug)

结局指标

主要结局

Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

时间窗: Baseline and EoT (up to 12 weeks)

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

时间窗: Baseline and EoT (up to 12 weeks)

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

次要结局

  • Change From Baseline to EoT in Mean Volume Voided Per Micturition(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)(Baseline and EoT (up to 12 weeks))
  • Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and weeks 4, 8 and 12)
  • Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours(Baseline and weeks 4, 8 and 12)
  • Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition(Baseline and weeks 4, 8 and 12)
  • Change From Baseline to EoT in Corrected Micturition Frequency(Baseline and Week 12)
  • Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes(Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Number of Pads Used at Weeks 4, 8, 12 and EoT(Weeks 4, 8 and 12 (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used(Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours(Baseline and weeks 4, 8 and 12 (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT(Week 12 and EoT (up to 12 weeks))
  • PGIC Scale: Impression in General Health at Week 12 and EoT(Week 12 and EoT (up to 12 weeks))
  • Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT(Weeks 4, 8,12 and EoT (up to 12 weeks))
  • Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)(Baseline and weeks 4, 8, 12, EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score(Baseline and weeks 4, 8 and 12)
  • Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment(Baseline and week 12 and EoT (up to 12 weeks))
  • Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression(Baseline and EoT (up to 12 weeks))
  • Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed(Baseline and week 12 and EoT (up to 12 weeks))
  • Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working(Baseline and week 12 and EoT (up to 12 weeks))
  • Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment(Baseline and week 12 and EoT (up to 12 weeks))
  • Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 8 and 12 in TS-VAS(Baseline and week 4, 8 and 12)
  • Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT(Weeks 4, 8 , 12 and EoT (up to 12 weeks))
  • Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT(Weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks))
  • Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume(Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference(Baseline and weeks 4, 12 and EoT (up to 12 weeks))
  • Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference(Baseline and weeks 4, 12 and EoT (up to 12 weeks))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (435)

Loading locations...

相似试验

已完成
3 期
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive BladderUrinary Bladder OveractiveUrgency IncontinenceUrinary Bladder Diseases\Urologic DiseasesOveractive Bladder
NCT02045862Astellas Pharma Europe B.V.1,829
已完成
2 期
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive BladderUrologic DiseasesUrinary Bladder DiseasesSigns and SymptomsUrinary Bladder, OveractiveUrological Manifestations
NCT01340027Astellas Pharma Europe B.V.1,307
已完成
4 期
Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)Benign Prostate HyperplasiaTransurethral Resection of ProstatePhotoselective Vaporization ProstatectomyOveractive Bladder
NCT01747577Astellas Pharma Korea, Inc.68
已完成
3 期
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)Osteoarthritis
NCT00092352Merck Sharp & Dohme LLC395
已完成
3 期
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)Osteoarthritis
NCT00092365Merck Sharp & Dohme LLC413