Nocturia
Conditions
Keywords
Nocturia, Hyptotension, Elderly, Males
Brief summary
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.
Detailed description
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
Interventions
DRUGVA106483
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
DRUGPlacebo
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
Sponsors
Vantia Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male aged 65 years of age and above * No clinically important abnormal physical, laboratory or vital sign findings in the opinion of the Investigator * Provision of written informed consent to participate * No recent alpha-blocker therapy * Not taking any concomitant medication known to be a cytochrome 3A4 inhibitor * Not taking any prescribed or over the counter medications unless agreed with the Investigator and Sponsor * No evidence of serious pathology or disease including poorly controlled endocrine disorders; active liver or biliary disease or severe kidney problems; syndrome of inappropriate antidiuretic hormone secretion * No history of orthostatic hypotension or syncope. * No known hypersensitivity to the IMP or alpha blocker, including severe lactose intolerance. * No history of drug or alcohol abuse * Negative for HIV, hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure, Heart rate | For 8 hours after dosing |
Countries
United Kingdom
Outcome results
None listed