Nocturia Clinical Trial
Official title:
A Single Centre, Double-blind, Placebo Controlled Crossover Study in Elderly Male Subjects to Investigate the Plarmacodynamic Interaction of VA106483 Administered Concomitanctly With Alpha-blocker Therapy
The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined
as waking to urinate at least once per night between periods of sleep). Nocturia is a
condition that often worsens as sufferers get older. This may be due to an over-active
bladder muscle, the bladder being able to hold less urine at night-time or over production
of urine in the bladder at night. Some of the treatments available for nocturia have
side-effects which make them unsuitable for elderly patients. These side-effects have not
been seen in studies with VA106483, which makes it potentially suitable for treating elderly
patients.
Nocturia is commonly associated with Benign Prostatic Hypertrophy (or BPH, a non-cancerous
enlargement of the prostate gland, which often results in problems passing water). Of the
patients who suffer from BPH, an estimated 40-85% experience the symptoms of waking at night
to pass water.
Treatments which are commonly prescribed for BPH include alpha-blockers which work by
improving urine flow by a muscle relaxant effect. Alpha-blockers are known to cause
hypotension (lowering of blood pressure which can cause dizziness in some patients) . Since
it is likely that subjects may be co-prescribed VA106483 and alpha-blockers, the purpose of
this study is to determine that giving VA106483 does not increase the hypotensive effects of
alpha-blockers
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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