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VA106483 and Alpha Blocker Interaction Study in Elderly Males

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
VA106483
Placebo
Sponsored by
Vantia Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Nocturia, Hyptotension, Elderly, Males

Eligibility Criteria

65 Years - undefined (Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Charles River Clinical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sugar pill

VA106483

Arm Description

Outcomes

Primary Outcome Measures

Blood pressure, Heart rate

Secondary Outcome Measures

Full Information

First Posted
April 8, 2009
Last Updated
November 24, 2009
Sponsor
Vantia Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00879216
Brief Title
VA106483 and Alpha Blocker Interaction Study in Elderly Males
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vantia Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
Nocturia, Hyptotension, Elderly, Males

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Title
VA106483
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VA106483
Intervention Description
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
Primary Outcome Measure Information:
Title
Blood pressure, Heart rate
Time Frame
For 8 hours after dosing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Charles River Clinical Services, Edinburgh, UK
Official's Role
Study Director
Facility Information:
Facility Name
Charles River Clinical Services
City
Edinburgh
ZIP/Postal Code
EH12 1DF
Country
United Kingdom

12. IPD Sharing Statement

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VA106483 and Alpha Blocker Interaction Study in Elderly Males

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