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NCT01348880 · ClinicalTrials.gov registry record · Phase 1
Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01348880 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 42 participants.
The verdict
NCT01348880, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Vardenafil ODT, (Staxyn, BAY38-9456)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01348880
The ClinicalTrials.gov registry entry for NCT01348880 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01348880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01348880 about?
NCT01348880 is a clinical study titled "Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study". 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 blind...
What is the current status of trial NCT01348880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2011-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01348880?
The interventions under investigation include: Placebo (DRUG), Vardenafil ODT, (Staxyn, BAY38-9456) (DRUG).
Who is sponsoring clinical trial NCT01348880?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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