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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972268
• Other study ID #: JLP-1207-P3
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: August 2019
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: August 14, 2018
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin 0.2mg + Solifenacin 5mg
Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
• Tamsulosin 0.2mg + Placebo(Solifenacin)
Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of TUFS		12 weeks from baseline
Primary	change of total IPSS		12 weeks from baseline