Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia - Tabular View

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

June 19, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sexual encounter profile question 2 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Hardness of erection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Other diary based variables [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Official Title ^ICMJE

A Randomized, Open-Label, Multi-Center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Brief Summary

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Tadalafil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

530

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age: 18 years and older
Males with erectile dysfunction
Stable heterosexual relationship
Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Nitrate use
Other exclusion criteria apply according to Summary of Product Characteristics

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Colombia, Finland, Germany, Israel, Italy, Mexico, Netherlands, Norway, Peru, South Africa, Spain, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00668109

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study ID Numbers ^ICMJE

10893

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP