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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02972268

Enrollment

780

Registered

2016-11-23

Start date

2016-02-01

Completion date

2018-08-14

Last updated

2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

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

Interventions

DRUGTamsulosin 0.2mg + Solifenacin 5mg

Tamsulosin 0.2mg + Solifenacin 5mg for 12wks

DRUGTamsulosin 0.2mg + Placebo(Solifenacin)

Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
change of TUFS	12 weeks from baseline
change of total IPSS	12 weeks from baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026