Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction

PHASE3CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

October 31, 2003

Study Completion Date

August 31, 2004

Conditions
Erectile Dysfunction
Interventions
DRUG

Levitra (Vardenafil, BAY38-9456)

BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.

DRUG

Placebo

Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment

Trial Locations (26)

10016

New York

20770

Greenbelt

21093

Lutherville

28209

Charlotte

28412

Wilmington

28677

Statesville

30274

Riverdale

32257

Jacksonville

85023

Phoenix

90212

Beverly Hills

92101

San Diego

92128

San Diego

92404

San Bernardino

92660

Newport Beach

92618-3603

Irvine

06611

Trumbull

08648

Lawrenceville

08901

New Brunswick

T2V 4R6

Calgary

L4M 4S5

Barrie

L7N 3V2

Burlington

N2M 5N4

Kitchener

N6A 4V2

London

L6H 3P1

Oakville

S7M 0Z9

Saskatoon

V8T 5G1

Victoria

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Bayer

INDUSTRY

NCT00657033 - Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction | Biotech Hunter | Biotech Hunter