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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00654914 |
The primary objective of this study is to assess the efficacy together with safety of a flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay 38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated with sildenafil in the previous <6 months .
At entry, once the Inclusion and Exclusion criteria are confirmed, the study medication will be administered for twelve weeks in an open label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily for the first four weeks of treatment. At the Investigators' discretion, on the basis of efficacy and safety evaluations, the patients may, then, receive the same dose strength of their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5 mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of treatment. Previous dose level of vardenafil is either maintained, increased or decreased by one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment, the patient will be contacted twenty four hours following the last visit in order to collect data concerning serious adverse events.
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A National, Multicentre, Open Label, Flexible Dose, Twelve Week Treatment to Assess the Efficacy and Safety of 5mg, 10mg and 20mg Bay 38-9456, a Phosphodiesterase Type V Inhibitor, in the Treatment of Male Patients With Erectile Dysfunction |
Enrollment: | 500 |
Study Start Date: | May 2003 |
Study Completion Date: | February 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental
n/a
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Drug: Levitra (Vardenafil, BAY38-9456)
Open label period with patient allocation to 10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A) Previous or current Medical Conditions
B) Concomitant Medication
C) Abnormal Laboratory Values
D) Other Exclusion Criteria
Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
Study ID Numbers: | 10781, VIS |
Study First Received: | April 4, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00654914 |
Health Authority: | Italy: Ministry of Health |
Sexual Dysfunction |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological Mental Disorders |
Benzocaine Genital Diseases, Male Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |