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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668109

Purpose

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

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Tadalafil	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Erectile Dysfunction High Blood Pressure

Drug Information available for: Tadalafil Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	530
Study Start Date:	December 2003
Study Completion Date:	June 2004

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg one hour prior to sexual intercourse
Active Comparator: Arm 2	Drug: Tadalafil 10 mg taken approximately 24 hours prior to sexual intercourse

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668109

Show 75 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00668109 History of Changes
Other Study ID Numbers:	10893
Study First Received:	April 24, 2008
Last Updated:	June 19, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; South Africa: Medicines Control Council; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Netherlands: Medicines Evaluation Board (MEB); Israel: Ministry of Health; Norway: Norwegian Medicines Agency; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: Federal Commission for Protection Against Health Risks; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Bayer:

Erectile Dysfunction
Diabetes mellitus
Hypertension
Hyperlipidemia
Vardenafil

Additional relevant MeSH terms:

Hyperlipidemias
Hypertension
Erectile Dysfunction
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

Mental Disorders
Tadalafil
Vardenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012