Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

NCT ID: NCT00668135

Last Updated: 2014-12-17

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

PHASE4

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-04-30

Brief Summary

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To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

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 1

Group Type EXPERIMENTAL

Vardenafil (Levitra, BAY38-9456)

Intervention Type DRUG

Vardenafil 10 mg orally on demand prior to intercourse

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Vardenafil (Levitra, BAY38-9456)

Vardenafil 10 mg orally on demand prior to intercourse

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: 20 years and older- Males with erectile dysfunction

Exclusion Criteria

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

20 Years

Maximum Eligible Age

65 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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Hong Kong, , Hong Kong

Site Status

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Petlaing Jaya, Salangor, Malaysia

Site Status

Kuching, Sarawak, Malaysia

Site Status

Kuala Lumpur, , Malaysia

Site Status

Kuala Lumpur, , Malaysia

Site Status

Manila, , Philippines

Site Status

Manila, , Philippines

Site Status

Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

Bangkok, Bangkok, Thailand

Site Status

Bangkok, Bangkok, Thailand

Site Status

Countries

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China Hong Kong Indonesia Malaysia Philippines Singapore Thailand

Other Identifiers

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10657

Identifier Type: -

Identifier Source: org_study_id