check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

12826

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2007-006678-27

EU CT Number:

Not Available
BAY38-9456 Multiple-dose study to investigate AE heartburn

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

45 - 70 Years
  • -

  • -

Trial summary

Enrollment Goal
23
Trial Dates
February 2008 - August 2008
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Vardenafil ER (BAY38-9456)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Bayer HealthCareWuppertal, 42096, Germany

Trial design

Randomized, double-blind, placebo-controlled study with a 2-way crossover design in stage I to investigate the incidence of the adverse event heartburn following repeated administration of 20 mg vardenafil extended release tablets in healthy female and male subjects followed by a subsequent stage II with randomized, double-blind, 3-way crossover, multiple-dose design of vardenafil extended release tablets with and without tartaric acid compared to tartaric acid alone to investigate the tolerability in the same study population
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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