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

Sponsor:	Bayer
Collaborator:	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
Safety	Drug: Sildenafil Drug: Placebo Drug: Vardenafil (Levitra, BAY38-9456)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Sildenafil Sildenafil citrate Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The change from baseline in Fansworth Munsell (FM) 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebo [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

The change from baseline in Electroretinogram (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 [ Time Frame: 8 weeks ]
Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dose [ Time Frame: 8 weeks ]
Safety and tolerability of 20 mg vardenafil after at least 15 oral doses of 20 mg vardenafil or placebo (dosed over approximately 8 weeks) [ Time Frame: 8 weeks ]
ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mg [ Time Frame: 8 weeks ]

Enrollment:	63
Study Start Date:	February 2005
Study Completion Date:	October 2006

Arms	Assigned Interventions
Active Comparator: Part A1	Drug: Sildenafil A1) Two dosis of 200 mg Sildenafil orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).
Placebo Comparator: Part A2	Drug: Placebo A2) Matching Placebo orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).
Experimental: Part B1	Drug: Vardenafil (Levitra, BAY38-9456) B1) At least 15 dosis of 20 mg Levitra orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).
Placebo Comparator: Part B2	Drug: Placebo B2) Matching Placebo orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).

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

Exclusion Criteria:

Any unstable medical, psychiatric, or substance abuse disorder
History of moderate or severe hepatic impairment
Creatinine clearance
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
History of trauma or surgery to either eye, of retinitis pigmentosa, of diabetes or current diabetes, of epilepsy or 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
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

Contacts and Locations

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

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00461565 History of Changes
Other Study ID Numbers:	11337, VAR 102 162
Study First Received:	April 17, 2007
Last Updated:	March 9, 2009
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

Additional relevant MeSH terms:

Sildenafil
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012