A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate with 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Astellas Pharma US, Inc.0 个研究点目标入组 195 人开始时间: 2007年6月18日最近更新: 2014年10月7日

适应症

试验速览

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•- Male subject and is at least 45 years of age.
•- Institutional Review Board (IRB)-approved written Informed Consent and HIPAA Authorization for U.S. sites, or equivalent privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures including withdrawal of prohibited medication.
•- Willing and able to complete the 3-day micturition diary and questionnaires correctly.
•- Voiding and storage lower urinary tract symptoms for at least 3 months.
•- Total IPSS (International Prostate Symptom Score) = 8.
•- Bladder Outlet Obstruction (BOO) indicated by a Bladder Outlet Obstruction Index (BOOI) = 20.
•- Maximum urinary flow rate of = 12 mL/sec, with a voided volume of =120 mL during free flow in a representative assessment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- History of urinary retention in the preceding 12 months.
•- Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months.
•- History or diagnosis of any of the following urinary conditions: Chronic inflammation such as chronic prostatitis, Stone in bladder or ureter, Other causes of outflow tract obstruction, such as bladder neck stenosis and urethral strictures.
•- Diagnosis or history of carcinoma (including prostate cancer) or previous pelvic radiation therapy, except non metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
•- Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
•- Total daily urine volume > 3000 mL as verified in the 3-day micturition diary at Baseline
•- Renal or hepatic impairment (2 X ULN values in any parameters and considered clinically significant by the Investigator) as indicated on screening laboratory results

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