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Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

NCT ID: NCT00656188

Last Updated: 2013-10-10

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-05-31

Brief Summary

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This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Vardenafil

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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Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Arm 1

Group Type ACTIVE_COMPARATOR

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Interventions

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Levitra (Vardenafil, BAY38-9456)

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month

Exclusion Criteria

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

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

Other Identifiers

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GSK 001

Identifier Type: -

Identifier Source: secondary_id

10898

Identifier Type: -

Identifier Source: org_study_id