Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
National Center for Research Resources (NCRR)
Phase 1/Phase 2
This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication children
take to treat congenital adrenal hyperplasia (CAH).
Drug Discrimination in Methadone-Maintained Humans Study 1
University of Arkansas
This study involves giving psychoactive drugs intramuscularly (injected into the muscle of
the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the
difference between one drug and another, as well as measuring the effects of the drugs on
mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each
subject will receive 2-4 of the listed interventions.
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 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.
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