Phase 3
N=1,066
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Lower Urinary Tract Symptoms · Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01021332 ↗Enrolled (actual)
1,066
Serious AEs
6.0%
Results posted
Jan 2016
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 499; 255; 12; 69 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
499; 255; 12; 69 | — |
| PRIMARY Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume |
10.7 | — |
| PRIMARY Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
4.54 | — |
| PRIMARY Change From Baseline to End of Treatment in Average Flow Rate (Qmean) |
2.05 | — |
| PRIMARY Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) |
-9.0 | — |
| PRIMARY Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) |
-10.1 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
-2.5 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition |
39.0 | — |
| SECONDARY Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition |
16.6 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours |
-3.1 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
-1.5 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
-1.4 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours |
-0.7 | — |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours |
-0.9 | — |
| SECONDARY Change From Baseline to End of Treatment in IPSS Voiding Score |
-4.7 | — |
| SECONDARY Change From Baseline to End of Treatment in IPSS Storage Score |
-4.3 | — |
| SECONDARY Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score |
-1.9 | — |
| SECONDARY Change From Baseline to End of Treatment in Individual IPSS Scores |
-1.3; -1.7; -1.0; -1.8; -1.6; -0.8 | — |
| SECONDARY Change From Baseline to End of Treatment in Symptom Bother Score |
-20.6 | — |
| SECONDARY Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score |
17.3 | — |
| SECONDARY Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score |
15.0 | — |
| SECONDARY Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score |
15.3 | — |
| SECONDARY Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score |
7.6 | — |
| SECONDARY Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score |
14.3 | — |
| SECONDARY Number of OAB-q Responders Based on Health-related Quality of Life: Total Score |
55.7 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Mobility Score |
775; 58; 1; 0; 67; 102 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Self-care Score |
934; 27; 1; 0; 18; 19 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Usual Activities Score |
805; 54; 1; 0; 80; 60 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score |
499; 71; 2; 0; 202; 200 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score |
737; 37; 1; 0; 103; 109 | — |
| SECONDARY Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score |
6.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
Exclusion Criteria
- Any significant PVR volume (>150 mL)
Data sourced from ClinicalTrials.gov (NCT01021332). 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.