MedDataX Logo

VA106483 and Alpha Blocker Interaction Study in Elderly Males

NCT ID: NCT00879216

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Nocturia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nocturia Hyptotension Elderly Males

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

VA106483

Group Type EXPERIMENTAL

VA106483

Intervention Type DRUG

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VA106483

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Intervention Type DRUG

Placebo

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vantia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles River Clinical Services, Edinburgh

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Charles River Clinical Services, Edinburgh, UK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charles River Clinical Services

Edinburgh, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

483-003

Identifier Type: -

Identifier Source: org_study_id