A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction

NCT ID: NCT01802359

Last Updated: 2017-06-22

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

TERMINATED

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-07

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

Detailed Description

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This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mirodenafil

No intervention

Intervention Type DRUG

This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.

Interventions

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No intervention

This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants diagnosed with erectile dysfunction
* Participants prescribed mirodenafil on demand

Exclusion Criteria

\- Participants who have administered mirodenafil for other than an approved indication
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

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MIRODENEDY4002

Identifier Type: OTHER

Identifier Source: secondary_id

MIR-KOR-PMS

Identifier Type: OTHER

Identifier Source: secondary_id

CR100836

Identifier Type: -

Identifier Source: org_study_id

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