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

MedlinePlus related topics: Diabetes Erectile Dysfunction High Blood Pressure

Drug Information available for: Tadalafil Vardenafil

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
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg one hour prior to sexual intercourse
Arm 2: Active Comparator	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

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Locations

Belgium

ROESELARE, Belgium, 8800

BRUXELLES - BRUSSEL, Belgium, 1070

EDEGEM, Belgium, 2650

BRUXELLES - BRUSSEL, Belgium, 1200
Colombia

Santa Fé de Bogotá, Colombia

Medellín, Colombia

Barranquilla, Colombia

Santafe de Bogotá, Colombia

Bogotá, Colombia
Finland

Oulu, Finland, 90100

Helsinki, Finland, 00100

Helsinki, Finland, 00180
Germany

Berlin, Germany, 13347

Berlin, Germany, 13465

Berlin, Germany, 13125

Hamburg, Germany, 20354
Germany, Baden-Württemberg

Freiburg, Baden-Württemberg, Germany, 79106

Stuttgart, Baden-Württemberg, Germany, 70372
Germany, Bayern

Weiden, Bayern, Germany, 92637

München, Bayern, Germany, 81925

Königsbrunn, Bayern, Germany, 86343

München, Bayern, Germany, 80333
Germany, Hessen

Marburg, Hessen, Germany, 35039
Germany, Niedersachsen

Hannover, Niedersachsen, Germany, 30625

Westerstede, Niedersachsen, Germany, 26655

Osnabrück, Niedersachsen, Germany, 49076
Germany, Nordrhein-Westfalen

Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Israel

Tel Aviv, Israel, 64239

Jerusalem, Israel, 91120

Haifa, Israel, 31096

Tel Hashomer, Israel, 52621
Italy

Milano, Italy, 20132

Milano, Italy, 20123

Milano, Italy, 20142

Perugia, Italy, 06126

Pisa, Italy, 56126

Catania, Italy, 95124

Padova, Italy, 35128

Pavia, Italy, 27100
Mexico

México, D.F., Mexico, 14080

México, D.F., Mexico, 14050

Durango, Mexico, 34000

México, D. F., Mexico, 06700
Mexico, Guerrero

Iguala, Guerrero, Mexico, 40000
Mexico, Nuevo León

Monterrey, Nuevo León, Mexico, 66260
Netherlands

UTRECHT, Netherlands, 3514 AB

NIJVERDAL, Netherlands, 7442 LS
Norway

Oslo, Norway, 0272

Moelv, Norway, 2390

Sarpsborg, Norway, 1700

Trondheim, Norway, 7006
Peru

Lima, Peru, LIMA 27

Lima, Peru, 33

Callao, Peru, CALLAO 2
South Africa, Eastern Cape

George, Eastern Cape, South Africa, 6530
South Africa, GAUTENG

Johannesburg, GAUTENG, South Africa, 2193
South Africa, Gauteng

Pretoria, Gauteng, South Africa, 0083
South Africa, Kwa Zulu Natal

Pietermaritzburg, Kwa Zulu Natal, South Africa, 3200
South Africa, Kwa Zulu-Natal

Newcastle, Kwa Zulu-Natal, South Africa, 2940
South Africa, KwaZulu Natal

Durban, KwaZulu Natal, South Africa, 4091
South Africa, KwaZulu- Natal

Durban, KwaZulu- Natal, South Africa, 4000

Durban, KwaZulu- Natal, South Africa, 4000
South Africa, KwaZulu-Natal

Durban, KwaZulu-Natal, South Africa, 3630
South Africa, Western Cape

Cape Town, Western Cape, South Africa, 7800

Cape Town, Western Cape, South Africa, 7505
Spain

A Coruña, Spain, 15006

Castellón de la Plana, Spain, 12004

Málaga, Spain, 29010

Palma de Mallorca, Spain, 07014

Zaragoza, Spain, 50009
Spain, Alicante

San Juan de Alicante, Alicante, Spain, 03550
Spain, Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Spain, Pontevedra

Vigo, Pontevedra, Spain, 36211
Sweden

Skövde, Sweden, 541 30

Stockholm, Sweden, 171 76

Borås, Sweden, 503 32

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	10893
Study First Received:	April 24, 2008
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00668109 History of Changes
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:

Sexual Dysfunctions, Psychological
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Phosphodiesterase Inhibitors

Vardenafil
Sexual Dysfunction, Physiological
Mental Disorders
Tadalafil
Cardiovascular Diseases
Erectile Dysfunction
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009