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

NCT ID: NCT02862483

Last Updated: 2016-08-12

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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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: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

Tamsulosin 0.2mg and Tadalafil 5mg

Group Type EXPERIMENTAL

Tamsulosin 0.2mg

Intervention Type DRUG

Tadalafil 5mg

Intervention Type DRUG

Comparator

placebo for Tamsulosin 0.2mg and Tadalafil 5mg

Group Type ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type DRUG

Placebo for Tamsulosin

Intervention Type DRUG

Interventions

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Tamsulosin 0.2mg

Intervention Type DRUG

Tadalafil 5mg

Intervention Type DRUG

Placebo for Tamsulosin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Visit1

* Male aged 45 years old or older
* Subjects who have PSA ≤ 4.0 ng/mL Visit2
* Subjects who have Total IPSS score ≥ 13
* Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4

Exclusion Criteria

* Subjects who have hypersensitivity to investigational product or sulfa medications
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catholic university of korea, Seoul ST. Mary's Hospital.

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji-yoon Choi

Role: CONTACT

Other Identifiers

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ID-TATA-301

Identifier Type: -

Identifier Source: org_study_id

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