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A Double-Blind Study to Evaluate the Pharmacodynamic Interaction Between 10 mg Vardenafil ODT (Orally Disintegrating Tablet) and Procardia XL® (Nifedipine GITS) in Elderly Male Patients With Both Hypertension and Erectile Dysfunction
The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 42 |
| Start date | 2011-05 |
| Completion | 2011-12 |
Conditions
- Erectile Dysfunction
Interventions
- Vardenafil ODT, (Staxyn, BAY38-9456)
- Placebo
Primary outcomes
- The primary pharmacodynamic variable (endpoint) is the placebo-corrected mean maximal decrease in supine systolic blood pressure from baseline (1 hour before dose) to within 8 hours of dosing with 10 mg ODT formulation of vardenafil HCl and nifedipine. — Up to 8 hours of combination dosing of vardenafil ODT and nifedipine.
Countries
United States