Lower Urinary Tract SymptomsPhase 3Neptune IINCT01021332
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
A Phase 3 study testing tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) and tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Astellas Pharma Europe B.V. at 70 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) and tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,067 participants
- Where
- 70 sitesin 11 countries
- Study dates
- 26 Apr 2010to 14 Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
Who cannot join
- Any significant PVR volume (>150 mL)
Trial locations and contacts
70 sites in 11 countries.
70 sites in 11 countries
Germany17 sites
Study site
Bautzen, 02625
Study site
Eisleben Lutherstadt, 06295
Study site
Frankfurt, 65933
Study site
Ganderkesee, 27777
Study site
Hagenow, 19230
Study site
Halle, 06132
Study site
Hamburg, 20253
Study site
Henningsdorf, 16761
Study site
Hettstedt, 06333
Study site
Koblenz, 56068
Study site
Leipzig, 04105
Study site
Leipzig, 04109
Study site
Neustadt in Sachsen, 01844
Study site
Radebeul, 01445
Study site
Sachsen, 06526
Study site
Trier, 54290
Study site
Uetersen, 25436
United Kingdom8 sites
Study site
Cardiff, CF14 5GJ
Study site
Chorley, PR7 7NA
Study site
Liverpool, L22 0LG
Study site
Northwood, HA6 2RN
Study site
Oxford, OX3 7LJ
Study site
Reading, RG2 7AG
Study site
Sheffield, S10 2JF
Study site
Taunton, TA1 5DA
Czechia7 sites
Study site
Hradec Králové, 500 02
Study site
Ostrava, 700 30
Study site
Pilsen, 301 24
Study site
Roudnice nad Labem, 413 01
Study site
Uherské Hradiště, 686 08
Study site
Ústí nad Labem, 400 01
Study site
Zd'ar Nad Sazavou, 591 01
Netherlands7 sites
Study site
Amsterdam, 100 AD
Study site
Apeldoorn, 7334 DZ
Study site
Doetinchem, 7009 BL
Study site
Maastricht, 6229 HX
Study site
Sneek, 8600 BA
Study site
Tilburg, 5022 GC
Study site
Winterswijk, 7101 BN
France6 sites
Study site
Colmar, 68024
Study site
Montluçon, 03100
Study site
Orléans, 45067
Study site
Paris, 75010
Study site
Paris, 75020
Study site
Pierre-Bénite, 69495
Poland6 sites
Study site
Bielsko-Biala, 43-300
Study site
Bydgoszcz, 85-094
Study site
Krakow, 31-530
Study site
Puławy, 24-100
Study site
Warsaw, 02-005
Study site
Więcbork, 89-410
Belgium5 sites
Study site
Antwerp, 2020
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Liège, 4000
Slovakia5 sites
Study site
Nitra, 949 01
Study site
Piešťany, 921 02
Study site
Prešov, 080 01
Study site
Skalica, 909 82
Study site
Trenčín, 911 01
Italy4 sites
Study site
Avellino, 83100
Study site
Catanzaro, 88100
Study site
Palermo, 90146
Study site
Treviglio, 24047
Belarus3 sites
Study site
Minsk, 220036
Study site
Minsk, 220119
Study site
Minsk, 223040
About this study
Official title: 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
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.
Read the detailed description
This is an open-label extension study following the double blind 905-CL-055 study
- Being tested
- tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg), tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
- Keywords
- Vesomni, Solifenacin succinate, EC905, Tamsulosin hydrochloride OCAS, Treatment, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)Drug
Also called EC905, Vesomni
oral
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)Drug
Also called EC905
oral
| Study group | Role | What they receive |
|---|---|---|
| Total Group | Experimental | Participants who received at least one dose of open-label fixed dose combination (FDC) treatment Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
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).
Measured: 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)
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
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).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
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.
Measured: Baseline and up to 52 weeks of FDC treatment
Secondary outcomes (25)
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: 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
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: 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
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: 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
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: 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
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: 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
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Individual IPSS Scores
The 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.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Measured: 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
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Measured: 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
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Measured: 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
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Measured: 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
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Measured: 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
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Measured: Baseline and up to 52 weeks of FDC treatment
Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Mobility Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Self-care Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Measured: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Measured: Baseline and up to 52 weeks of FDC treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study start26 Apr 2010
- Primary completion14 Dec 2011
- Study completion14 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021332
- Sponsor's protocol ID
- 905-CL-057
- Other IDs
- 2008-001212-20, 2008
- Acronym
- Neptune II
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2009
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01021332
- Acronym / sponsor ID
- Neptune II / 905-CL-057
- Keywords
- Vesomni, Solifenacin succinate, EC905, Tamsulosin hydrochloride OCAS, Treatment, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2010 (actual)
- Primary completion
- 14 Dec 2011 (actual)
- Study completion
- 14 Dec 2011 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Posted 22 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label extension study following the double blind 905-CL-055 study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Group | Experimental | 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)Participants who received at least one dose of open-label fixed dose combination (FDC) treatment |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
Key exclusion criteria (1 listed)
- Any significant PVR volume (>150 mL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)Also: EC905, Vesomnioral | Drug | Total Group |
| tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)Also: EC905oral | Drug | Total Group |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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])
Time frame: 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.
25 secondary outcomes
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Voiding Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Storage Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Individual IPSS Scores
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Symptom Bother Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and up to 52 weeks of FDC treatment
Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Mobility Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Self-care Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Time frame: Baseline and up to 52 weeks of FDC treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study chair
Astellas Pharma Global Development
70 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) and tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Astellas Pharma Europe B.V. at 70 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Germany, United Kingdom, Czechia, Netherlands, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.