FDA Phase IV - Commitment - Retinal Function Study - Full Text View

Sponsors and Collaborators:	Bayer GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00461565

Purpose

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).

Condition	Intervention	Phase
Healthy	Drug: Levitra (Vardenafil, BAY38-9456)	Phase IV

Drug Information available for: Sildenafil citrate Sildenafil Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	30
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461565

Locations

United States, Pennsylvania
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Bayer

GlaxoSmithKline

More Information

Study ID Numbers:	11337
Study First Received:	April 17, 2007
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00461565
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Retina
PDE-5
Levitra
Viagra
Normal healthy volunteers for evaluation of retinal function

Study placed in the following topic categories:

Vardenafil
Sildenafil
Healthy

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009