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VA106483 and Alpha Blocker Interaction Study in Elderly Males

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ClinicalTrials.gov Identifier: NCT00879216
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Nocturia Drug: VA106483 Drug: Placebo Phase 1

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2009
Primary Completion Date : May 2009
Study Completion Date : July 2009
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar pill Drug: Placebo
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
Experimental: VA106483 Drug: VA106483
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.


Outcome Measures

Primary Outcome Measures :
  1. Blood pressure, Heart rate [ Time Frame: For 8 hours after dosing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879216


Locations
United Kingdom
Charles River Clinical Services
Edinburgh, United Kingdom, EH12 1DF
Sponsors and Collaborators
Vantia Ltd
Investigators
Study Director: Medical Director Charles River Clinical Services, Edinburgh, UK
More Information

Responsible Party: Medical Director, Charles River Clinical Services, Edinburgh
ClinicalTrials.gov Identifier: NCT00879216     History of Changes
Other Study ID Numbers: 483-003
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Vantia Ltd:
Nocturia
Hyptotension
Elderly
Males

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs