Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

• Status: Completed
• Trial end date: 2018-08-14
• Target enrollment: 0
• Participant gender: Male

Summary

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• Over 45 years

• Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS

• Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

• Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years

• Subjects who have acute urinary retention within 12 weeks before screening

• Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening

• Subjects who have hypersensitivity to investigational product

• Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum

• Subjects who have myasthenia gravis, narrow angle glaucoma

• Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

• SBP > 180 mmHg or DBP > 100 mmHg

• HbA1c > 9.0 %

• Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.