FDA Phase IV - Commitment - Retinal Function Study
This study has been completed.
Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00461565
First received: April 17, 2007
Last updated: March 9, 2009
Last verified: March 2009
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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 4 |
| 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 hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
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 More Information
Additional Information:
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 May 23, 2013