Phase 3
N=1,334
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01018511 ↗Enrolled (actual)
1,334
Serious AEs
2.0%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline to End of Treatment in Total International Prostate Symptom Score — -5.4; -6.2; -7.0; -6.5 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo tamsulosin hydrochloride OCAS 0.4 mg (Drug); Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg (Drug); Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Drug); tamsulosin hydrochloride OCAS 0.4 mg (Drug); tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) (Drug); tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Astellas Pharma Europe B.V.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Treatment in Total International Prostate Symptom Score |
-5.4; -6.2; -7.0; -6.5 | 0.001 sig |
| PRIMARY Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) |
-4.4; -6.7; -8.1; -7.6 | 0.025 sig |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
-1.1; -1.7; -2.3; -1.9 | <0.001 sig |
| SECONDARY Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition |
11.1; 15.5; 38.6; 38.7 | < 0.001 sig |
| SECONDARY Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition |
-5.9; -1.8; 12.7; 12.9 | 0.053 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours |
-1.6; -2.5; -2.6; -2.8 | 0.616 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
-1.0; -1.4; -1.3; -1.1 | 0.591 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
0.1; -0.2; 0.0; 0.1 | 0.511 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours |
-0.3; -0.4; -0.5; -0.4 | 0.383 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours |
-0.7; -0.8; -1.2; -1.2 | 0.187 |
| SECONDARY Change From Baseline to End of Treatment in IPSS Voiding Score |
-3.0; -3.3; -3.7; -3.2 | 0.210 |
| SECONDARY Change From Baseline to End of Treatment in IPSS Storage Score |
-2.4; -2.9; -3.5; -3.3 | 0.009 sig |
| SECONDARY Change From Baseline to End of Treatment in IPSS QoL Score |
-0.9; -1.0; -1.3; -1.3 | 0.008 sig |
| SECONDARY Change From Baseline to End of Treatment in Individual IPSS Scores |
-0.9; -0.9; -1.0; -1.0; -1.0; -1.2 | — |
| SECONDARY Change From Baseline to End of Treatment in Symptom Bother Score |
-11.8; -14.4; -16.5; -17.1 | 0.068 |
| SECONDARY Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score |
8.8; 11.0; 13.9; 13.4 | 0.011 sig |
| SECONDARY Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score |
7.5; 9.3; 12.0; 11.5 | 0.013 sig |
| SECONDARY Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score |
8.3; 8.8; 11.9; 10.0 | 0.011 sig |
| SECONDARY Change From Baseline to End of Treatment in HRQoL Subscale: Social Score |
3.8; 4.5; 6.2; 5.8 | 0.043 sig |
| SECONDARY Change From Baseline to End of Treatment in HRQoL Subscale: Total Score |
7.4; 8.8; 11.4; 10.7 | 0.004 sig |
| SECONDARY Percentage of Participants Who Were OAB-q Responders at End of Treatment |
40.8; 42.9; 45.5; 47.5 | 0.874 |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Mobility Score |
240; 230; 255; 233; 16; 13 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Self-care Score |
295; 273; 293; 286; 8; 8 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Usual Activities Score |
254; 228; 248; 235; 18; 13 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score |
162; 159; 153; 152; 14; 14 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score |
219; 213; 233; 214; 16; 11 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score |
4.0; 3.7; 5.5; 6.2 | — |
| SECONDARY Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms |
7; 14; 20; 23; 75; 85 | <.001 sig |
| SECONDARY Patient Global Impression Scale at End of Treatment: General Health |
5; 9; 10; 7; 43; 58 | 0.053 |
| SECONDARY Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms |
9; 15; 22; 20; 95; 106 | 0.110 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
87; 74; 99; 100; 59; 42 | — |
| SECONDARY Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume |
-6.1; -5.0; 3.8; 12.3 | — |
| SECONDARY Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
3.3; 3.2; 3.8; 3.5 | — |
| SECONDARY Change From Baseline to End of Treatment in Average Flow Rate (Qmean) |
1.5; 1.3; 1.9; 1.7 | — |
| SECONDARY Apparent Clearance (CL/F) of Tamsulosin |
2.78; 2.61; 2.53; 2.62; 2.41; 2.36 | — |
| SECONDARY Maximum Concentration at Steady State (Cmaxss) of Tamsulosin |
7.38; 7.80; 8.00; 7.69; 8.32; 8.46 | — |
| SECONDARY Minimum Concentration at Steady State (Cminss) of Tamsulosin |
4.19; 4.55; 4.75; 4.63; 5.08; 5.19 | — |
| SECONDARY Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin |
5.04; 5.06; 5.08; 5.09; 5.10; 5.11 | — |
| SECONDARY Area Under the Curve at Steady State (AUCss) of Tamsulosin |
144; 153; 158; 153; 166; 169 | — |
| SECONDARY CL/F of Solifenacin |
6.88; 7.00; 6.72; 6.67; 6.94; 6.87 | — |
| SECONDARY Cmaxss of Solifenacin |
29.4; 43.4; 30.0; 45.3; 29.1; 44.1 | — |
| SECONDARY Cminss of Solifenacin |
24.5; 36.1; 25.2; 38.2; 24.4; 37.0 | — |
| SECONDARY Tmaxss of Solifenacin |
5.47; 5.47; 5.48; 5.48; 5.48; 5.48 | — |
| SECONDARY AUCss of Solifenacin |
657; 970; 673; 1020; 652; 988 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01018511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.