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LEVITRA® 20mg Special Drug Use Investigation (Long-term)

NCT ID: NCT00909233

Last Updated: 2014-12-15

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

COMPLETED

Total Enrollment

1221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-12-31

Brief Summary

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This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile dysfunction, Phosphodiesterase Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Vardenafil, (Levitra, BAY38-9456)

Intervention Type DRUG

Patients under daily life treatment receiving Levitra according to local drug information.

Interventions

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Vardenafil, (Levitra, BAY38-9456)

Patients under daily life treatment receiving Levitra according to local drug information.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Yakuhin Ltd

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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LV0701JP

Identifier Type: -

Identifier Source: secondary_id

13930

Identifier Type: -

Identifier Source: org_study_id