BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00668057
First received: April 24, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Erectile Function domain score of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 480
Study Start Date: December 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 3 Drug: Levitra (Vardenafil, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
Placebo Comparator: Arm 4 Drug: Placebo
5 mg matching placebo
Placebo Comparator: Arm 5 Drug: Placebo
10 mg matching placebo
Placebo Comparator: Arm 6 Drug: Placebo
20 mg matching placebo

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Other exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668057

Locations
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
China
Beijing, China, 100083
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100853
Shanghai, China, 200040
Shanghai, China, 200127
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668057     History of Changes
Other Study ID Numbers: 10690
Study First Received: April 24, 2008
Last Updated: October 9, 2013
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Bayer:
Male Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 21, 2014