NCT00879216

VA106483 and Alpha Blocker Interaction Study in Elderly Males

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	VA106483	4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
DRUG	Placebo	4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2009-04-09
• Last updated: 2009-11-25

Locations

1 site across 1 country: United Kingdom