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BAY38-9456 - Pivotal Trial for Diabetes Patient

NCT ID: NCT00678704

Last Updated: 2014-12-19

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

PHASE3

Total Enrollment

790 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-11-30

Brief Summary

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The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Detailed Description

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Conditions

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Erectile Dysfunction Diabetes Mellitus

Keywords

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Vardenafil PDE5 inhibitor Erectile Dysfunction Diabetes Mellitus Sexual Dysfunction

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 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet prior to intercourse on demand

Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

BAY 38-9456 10 mg tablet prior to intercourse on demand

Arm 2

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

BAY 38-9456 20 mg tablet prior to intercourse on demand

Interventions

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Levitra (Vardenafil, BAY38-9456)

BAY 38-9456 10 mg tablet prior to intercourse on demand

Intervention Type DRUG

Levitra (Vardenafil, BAY38-9456)

BAY 38-9456 20 mg tablet prior to intercourse on demand

Intervention Type DRUG

Placebo

Placebo tablet prior to intercourse on demand

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Diabetes for more than 3 years

Exclusion Criteria

* Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
* Spinal cord injury
* History of surgical prostatectomy (excluding TURP)
* Patients with an HbA1c \> 12% at Visit 1
* Use of nitrates
* Use of potent CYP3a4 inhibitors
* Severe liver disease
* Presence of Peyronie's Disease
Minimum Eligible Age

20 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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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

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100607

Identifier Type: -

Identifier Source: org_study_id