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

NCT ID: NCT00668109

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-06-30

Brief Summary

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

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Diabetes mellitus Hypertension Hyperlipidemia Vardenafil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

10 mg one hour prior to sexual intercourse

Arm 2

Group Type ACTIVE_COMPARATOR

Tadalafil

Intervention Type DRUG

10 mg taken approximately 24 hours prior to sexual intercourse

Interventions

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Levitra (Vardenafil, BAY38-9456)

10 mg one hour prior to sexual intercourse

Intervention Type DRUG

Tadalafil

10 mg taken approximately 24 hours prior to sexual intercourse

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Bruxelles - Brussel, , Belgium

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Bruxelles - Brussel, , Belgium

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Edegem, , Belgium

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Roeselare, , Belgium

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Medellín, , Colombia

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Santa Fé de Bogotá, , Colombia

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Helsinki, , Finland

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Helsinki, , Finland

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Oulu, , Finland

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Königsbrunn, Bavaria, Germany

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München, Bavaria, Germany

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München, Bavaria, Germany

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Weiden, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Marburg, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Osnabrück, Lower Saxony, Germany

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Westerstede, Lower Saxony, Germany

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Mönchengladbach, North Rhine-Westphalia, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Haifa, Israel, Israel

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Jerusalem, Israel, Israel

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Tel Aviv, Israel, Israel

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Tel Litwinsky, , Israel

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Catania, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Padua, , Italy

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Pavia, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Durango, Durango, Mexico

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Iguala de la Independencia, Guerrero, Mexico

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México, D. F., México, D. F., Mexico

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Monterrey, Nuevo León, Mexico

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México, D.F., , Mexico

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México, D.F., , Mexico

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Nijverdal, , Netherlands

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Utrecht, , Netherlands

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Moelv, , Norway

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Oslo, , Norway

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Sarpsborg, , Norway

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Trondheim, , Norway

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Callao, , Peru

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Lima, , Peru

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Lima, , Peru

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George, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Newcastle, KwaZulu-Natal, South Africa

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Pietermaritzburg, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Cape Town, Western Cape, South Africa

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A Coruña, A Coruña, Spain

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Sant Joan d'Alacant, Alicante, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Castellon, Castellón de La Plana, Spain

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Málaga, Málaga, Spain

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Palma de Mallorca, Palma de Mallorca, Spain

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Vigo, Pontevedra, Spain

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Zaragoza, Zaragoza, Spain

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Borås, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Countries

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

Other Identifiers

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10893

Identifier Type: -

Identifier Source: org_study_id