CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Vardenafil (Levitra, BAY38-9456) +1 moredrug
Likely dose
Vardenafil (Levitra, BAY38-9456) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00738400
NCT00738400Phase 4Completed
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Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

Bayer·interventional·Posted Aug 20, 2008·Updated Nov 16, 2015

In Brief

A Phase 4 clinical trial evaluating Vardenafil (Levitra, BAY38-9456) and Placebo for Erectile Dysfunction and Metabolic Syndrome. Completed, enrolled 150 participants across 19 sites.

Detailed Summary

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction, Metabolic Syndrome
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 20, 2008
Enrollment StartNov 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.9 years ago

Interventions

Vardenafil (Levitra, BAY38-9456)drug

Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks

Placebodrug

Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks