FDA Phase IV - Commitment - Retinal Function Study

NCT00461565 | Completed Phase 4

• 2 other identifiers: 11337VAR 102 162
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Safety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (4)

• 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

  8 weeks

• Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dose

  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)

  8 weeks

• ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mg

  8 weeks

Study Arms (4)

Part A1

ACTIVE COMPARATOR

Drug: Sildenafil

Part A2

PLACEBO COMPARATOR

Drug: Placebo

Part B1

EXPERIMENTAL

Drug: Vardenafil (Levitra, BAY38-9456)

Part B2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sildenafil DRUG

A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part A1

Placebo DRUG

A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part A2

Vardenafil (Levitra, BAY38-9456) DRUG

B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part B1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Bayer: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Interventions

Sildenafil Citrate; Vardenafil Dihydrochloride

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: February 1, 2005
• Study Completion: October 1, 2006
• Last Updated: March 19, 2015

Record last verified: 2015-03