FDA Phase IV - Commitment - Retinal Function Study

Bayer

Status and phase: Completed; Phase 4

Conditions: Safety

Treatments: Drug: Vardenafil (Levitra, BAY38-9456); Drug: Sildenafil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461565

VAR 102 162 (Other Identifier)

11337

Details and patient eligibility

About

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).

Enrollment: 63 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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63 participants in 4 patient groups, including a placebo group

Part A1

Active Comparator group

Treatment:

Drug: Sildenafil

Part A2

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Part B1

Experimental group

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)

Part B2

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo