Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

FDA Phase IV - Commitment - Retinal Function Study

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00461565
First received: April 17, 2007
Last updated: March 9, 2009
Last verified: March 2009

April 17, 2007
March 9, 2009
February 2005
Not Provided
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 ]
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
Complete list of historical versions of study NCT00461565 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Not Provided
Not Provided
 
FDA Phase IV - Commitment - Retinal Function Study
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

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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Safety
  • 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).
  • Drug: Placebo
    A2) Matching Placebo orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).
  • 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).
  • Drug: Placebo
    B2) Matching Placebo orally. Patiens receive either A1) or A2) in cross over design with either B1) or B2).
  • Active Comparator: Part A1
    Intervention: Drug: Sildenafil
  • Placebo Comparator: Part A2
    Intervention: Drug: Placebo
  • Experimental: Part B1
    Intervention: Drug: Vardenafil (Levitra, BAY38-9456)
  • Placebo Comparator: Part B2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
October 2006
Not Provided

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00461565
11337, VAR 102 162
No
Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
Bayer
GlaxoSmithKline
Study Director: Bayer Study Director Bayer
Bayer
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP