Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02972268

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

COMPLETED PHASE3

The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction

NCT02862483

Benign Prostatic Hyperplasia Erectile Dysfunction

UNKNOWN PHASE3

Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

NCT01018511

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

COMPLETED PHASE3

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

NCT02180997

LUTS Benign Prostatic Hyperplasia Overactive Bladder

COMPLETED PHASE1

Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

NCT02715024

Lower Urinary Tract Symptoms Overactive Bladder Benign Prostatic Hyperplasia (BPH)

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostate Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tamsulosin + Solifenacin

Tamsulosin and Solifenacin

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin

Solifenacin

Intervention Type DRUG

Solifenacin

Tamsulosin + Solifenacin Placebo

Tamsulosin and Solifenacin placebo

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Tamsulosin

Solifenacin placebo

Intervention Type DRUG

Solifenacin placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tamsulosin

Intervention Type DRUG

Solifenacin

Intervention Type DRUG

Solifenacin placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy male aged 45 years old or older
2. Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
3. Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria

1. Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years
2. Subjects who have acute urinary retention within 4 weeks before screening
3. Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
4. Subjects who have hypersensitivity to investigational product or sulfa medications
5. Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
6. Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy
7. Subjects who have cataract or glaucoma scheduled to be operated in the study duration.
8. Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9. Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No