VA106483 and Alpha Blocker Interaction Study in Elderly Males

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879216
• Other study ID #: 483-003
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2009
• Last updated: November 24, 2009
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• VA106483
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
• Placebo
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Locations

Country	Name	City	State
United Kingdom	Charles River Clinical Services	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Vantia Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure, Heart rate		For 8 hours after dosing	Yes