Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Neptune II
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
2 other identifiers
interventional
1,067
10 countries
67
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2010
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 26, 2009
CompletedStudy Start
First participant enrolled
April 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2011
CompletedResults Posted
Study results publicly available
January 22, 2016
CompletedDecember 3, 2024
November 1, 2024
1.6 years
November 24, 2009
October 14, 2015
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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).
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.
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.
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.
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).
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.
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
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
- +20 more secondary outcomes
Study Arms (1)
Total Group
EXPERIMENTALParticipants who received at least one dose of open-label fixed dose combination (FDC) treatment
Interventions
oral
oral
Eligibility Criteria
You may qualify if:
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
You may not qualify if:
- Any significant PVR volume (\>150 mL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Unknown Facility
Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Minsk, 220036, Belarus
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Minsk, 220119, Belarus
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Minsk, 223040, Belarus
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Antwerp, 2020, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Hradec Králové, 500 02, Czechia
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Ostrava, 700 30, Czechia
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Pilsen, 301 24, Czechia
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Roudnice nad Labem, 413 01, Czechia
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Uherské Hradiště, 686 08, Czechia
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Ústí nad Labem, 400 01, Czechia
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Zd'ar Nad Sazavou, 591 01, Czechia
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Colmar, 68024, France
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Montluçon, 03100, France
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Orléans, 45067, France
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Paris, 75010, France
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Paris, 75020, France
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Pierre-Bénite, 69495, France
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Bautzen, 02625, Germany
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Eisleben Lutherstadt, 06295, Germany
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Frankfurt, 65933, Germany
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Ganderkesee, 27777, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Hamburg, 20253, Germany
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Henningsdorf, 16761, Germany
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Hettstedt, 06333, Germany
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Koblenz, 56068, Germany
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Leipzig, 04105, Germany
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Leipzig, 04109, Germany
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Neustadt in Sachsen, 01844, Germany
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Radebeul, 01445, Germany
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Sachsen, 06526, Germany
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Trier, 54290, Germany
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Uetersen, 25436, Germany
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Avellino, 83100, Italy
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Catanzaro, 88100, Italy
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Palermo, 90146, Italy
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Treviglio, 24047, Italy
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Amsterdam, 100 AD, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Maastricht, 6229 HX, Netherlands
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Sneek, 8600 BA, Netherlands
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Tilburg, 5022 GC, Netherlands
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Winterswijk, 7101 BN, Netherlands
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Bielsko-Biala, 43-300, Poland
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Bydgoszcz, 85-094, Poland
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Krakow, 31-530, Poland
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Puławy, 24-100, Poland
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Warsaw, 02-005, Poland
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Więcbork, 89-410, Poland
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Nitra, 949 01, Slovakia
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Piešťany, 921 02, Slovakia
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Prešov, 080 01, Slovakia
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Skalica, 909 82, Slovakia
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Trenčín, 911 01, Slovakia
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Cardiff, CF14 5GJ, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
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Reading, RG2 7AG, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Taunton, TA1 5DA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director, Global Medical Science
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 26, 2009
Study Start
April 26, 2010
Primary Completion
December 14, 2011
Study Completion
December 14, 2011
Last Updated
December 3, 2024
Results First Posted
January 22, 2016
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.