BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
1 other identifier
interventional
624
1 country
7
Brief Summary
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2002
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedMarch 6, 2015
March 1, 2015
9 months
April 24, 2008
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
12 weeks
Secondary Outcomes (3)
Global Assessment Questionnaire
12 weeks
Erectile Function domain score of the International Index of Erectile Function
12 weeks
Safety and tolerability
12 weeks
Study Arms (6)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
PLACEBO COMPARATORArm 5
PLACEBO COMPARATORArm 6
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
You may not qualify if:
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (7)
Unknown Facility
Hangzhou, Zhejiang, 310003, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Beijing, 100853, China
Unknown Facility
Shanghai, 200040, China
Unknown Facility
Shanghai, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
December 1, 2002
Primary Completion
September 1, 2003
Study Completion
September 1, 2003
Last Updated
March 6, 2015
Record last verified: 2015-03