LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

NCT ID: NCT01207947

Last Updated: 2015-01-21

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

491 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-03-31

Brief Summary

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Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.

In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

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

* Patients \>/= 18 years
* Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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LV0702JP

Identifier Type: OTHER

Identifier Source: secondary_id

13931

Identifier Type: -

Identifier Source: org_study_id

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