check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
15345
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
65 - 80 YearsTrial summary
Enrollment Goal
42Trial Dates
May 2011 - December 2011Phase
Phase 1Could I Receive a placebo
YesProducts
Vardenafil ODT (BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | New Orleans Center for Clinical Research | Knoxville, 37920, United States |
Completed | Clinical Pharmacology of Miami, Inc. | Miami, 33014, United States |
Primary Outcome
- 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.date_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipine.enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Mean maximal decrease in standing SBPdate_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Mean maximal decrease in standing diastolic blood pressure (DBP)date_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Mean maximal decrease in supine DBPdate_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Mean maximal orthostatic change in SBP (the supine SBP minus the standing SBP)date_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Mean maximal increase in supine and standing heart ratedate_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Mean area under effect curve (AUEC) in standing and supine systolic and diastolic blood pressure, and heart ratedate_rangeTime Frame:Up to 8 hours of combination dosing of vardenafil ODT and nifedipineenhanced_encryptionYesSafety Issue:
- Safety parametersSafety parameters included physical examinations, adverse events, laboratory values, electrocardiogram, concomitant medications, and vital signsdate_rangeTime Frame:up to end of studyenhanced_encryptionYesSafety Issue:
- Pharmacokinetics parameterdate_rangeTime Frame:1 and 2 weeks prior to the Day 1 dosing of the combination of nifedipine/vardenafil as well as at Visit 4 and Visit 5enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
2