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

Phase 3

Completed

• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin 0.2mg + Solifenacin 5mg; Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)

• Registration Number: NCT02972268
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-23
• Primary Completion: 2017-11-02
• Study Completion: 2018-08-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 780

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Tamsulosin 0.2mg + Solifenacin 5mg	Tamsulosin 0.2mg + Solifenacin 5mg
Group II	Tamsulosin 0.2mg + Placebo(Solifenacin)	Tamsulosin 0.2mg + Placebo(Solifenacin)

Primary Outcome Measures

Name	Time	Method
change of TUFS	12 weeks from baseline
change of total IPSS	12 weeks from baseline

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of