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VA106483 and Alpha Blocker Interaction Study in Elderly Males

This study has been completed.
Sponsor:
Information provided by:
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT00879216
First received: April 8, 2009
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Nocturia
 Drug: VA106483
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Blood pressure, Heart rate [ Time Frame: For 8 hours after dosing ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical Director, Charles River Clinical Services, Edinburgh
ClinicalTrials.gov Identifier: NCT00879216     History of Changes
Other Study ID Numbers: 483-003
Study First Received: April 8, 2009
Last Updated: November 24, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vantia Ltd:
Nocturia
Hyptotension
Elderly
Males

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

ClinicalTrials.gov processed this record on May 16, 2013