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Completed

NCT Number: NCT02972268

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

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tamsulosin 0.2mg + Solifenacin 5mg

Drug

Tamsulosin 0.2mg + Solifenacin 5mg for 12wks

Tamsulosin 0.2mg + Placebo(Solifenacin)

Drug

Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks

Primary outcomes

  1. change of TUFS

    Time frame: 12 weeks from baseline

  2. change of total IPSS

    Time frame: 12 weeks from baseline

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 23, 2016
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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