FDA Phase IV - Commitment - Retinal Function Study
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer
Summary
Vardenafil (Levitra®) and Sildenafil (Viagra®) are drugs that are marketed for use in
patients with erectile dysfunction. The purpose of this study is to find out if there are any
changes in the eye after taking at least 15 doses of Vardenafil and after two doses of
Sildenafil. This is a double-blind study, which means that neither you nor the study doctor
will know which treatment you are receiving. If you qualify for the study, you will receive:
- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There
will be two times when this occurs during the study.
- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the
study.
- Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).
Clinical Details
Official title: A Double Blind, Randomized, Placebo Controlled, Two Part, Two Session Balanced, Crossover Study to Evaluate Visual Changes in Healthy Male Subjects Aged 18 - 55 Years After Receiving: 1. at Least 15 Doses of 20 mg Vardenafil, Compared to Placebo and 2. Two Doses of Sildenafil, 200 mg Compared to Placebo
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: The change from baseline in FM 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebo
Secondary outcome: The change from baseline in ERG as measured by amplitude and implicit time of b wave in both the left and right eyes for vardenafil treated subjects as compared to placebo
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy adult male subjects between 18 and 55 years of age, inclusive, at screening
- Body mass index (BMI) 19 to 34 kg/m2
- Negative for HIV, Hepatitis B and Hepatitis C at screening
- Must provide written informed consent
Exclusion Criteria:
- Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of
the Investigator is likely to affect the subjects ability to complete the study or
precludes the subjects participation in the study
- History of moderate or severe hepatic impairment as defined by AST or ALT greater than
2 times the upper limit of normal
- Creatinine clearance (CrCl) less than 85 ml/min
- A resting systolic blood pressure of < 100 mm Hg or > 170 mm Hg or a resting diastolic
blood pressure > 110 mm Hg
- Blindness, color blindness or vision in either eye judged as abnormal by the
investigator; the use of glasses or contact lenses does not automatically exclude a
subject from the study
- History of trauma or surgery to either eye
- History of retinitis pigmentosa
- History of diabetes or current diabetes
- History of epilepsy
- History of seizure disorders
- Symptomatic hypotension within 6 months of start of study
- History of sickle cell anemia or sickle cell trait or bleeding disorder
- Significant active peptic ulceration or other gastrointestinal disorder such as
colitis or Crohn¿s Disease
- Known allergy to tropicamide and/or oxybuprociaine
- History or presence of allergy to the PDE-5 inhibitors, or a history of drug or other
allergy that, in the opinion of the Investigator, contraindicates their participation
- Use of alpha blockers, nitrates, ritonavir, indinavir, ketoconazole, itraconazole, or
erythromycin, ciprofloxacin, tadalafil, isotretinoin, ibuprofen, unoprostone
isopropyl, Lily-of-the-Valley, Strophanthus, ranitidine and sildenafil
- Blood collection of greater than 500 ml within 56 days prior to study start
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is
longer) preceding the first dose of investigational product
- History of regular alcohol consumption exceeding 14 drinks/week (average) for men (1
drink = 5 ounces of wine or 12 ounces of beer or 1. 5 ounces of hard liquor) within 6
months of screening
- A positive urine drug screen
Locations and Contacts
Scheie Eye Institute, Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: February 2005
Last updated: April 17, 2007
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