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

Jeil Pharmaceutical logo

Jeil Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Treatments

Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)
Drug: Tamsulosin 0.2mg + Solifenacin 5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02972268
JLP-1207-P3

Details and patient eligibility

About

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

Enrollment

780 patients

Sex

Male

Ages

45+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

780 participants in 2 patient groups, including a placebo group

Group I
Experimental group
Description:
Tamsulosin 0.2mg + Solifenacin 5mg
Treatment:
Drug: Tamsulosin 0.2mg + Solifenacin 5mg
Group II
Placebo Comparator group
Description:
Tamsulosin 0.2mg + Placebo(Solifenacin)
Treatment:
Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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