Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
NCT ID: NCT02715024
Last Updated: 2016-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2007-09-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamsulosin alone
Tamsulosin
Oral
Tamsulosin + solifenacin
Tamsulosin
Oral
Solifenacin
Oral
Interventions
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Tamsulosin
Oral
Solifenacin
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* I-PSS(S) score of ≥ 12
* Maximum flow rate (Qmax) of 4 to15 mL/sec
* Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
* Benign digital rectal examination (DRE) result
Exclusion Criteria
* Significant post void residue volume (PVR \>100ml)
* Prostate specific antigen (PSA) ≥10 ng/mL
* Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
* Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
* Patient with a neurological cause for abnormal detrusor activity
* Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
* Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
* Patients with any other complication which may cause voiding dysfunction
* Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
* Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
* Use of drugs to treat incontinence currently
* Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Patients had taken any investigational drug in the previous 3 months prior to this study
45 Years
MALE
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Therapeutic Area Lead of Medical Affairs (Asia-Oceania)
Role: STUDY_DIRECTOR
Astellas Pharma Taiwan, Inc.
Locations
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Site
Taipei, , Taiwan
Countries
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Other Identifiers
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HAURO-0605-TW
Identifier Type: -
Identifier Source: org_study_id
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