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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations
Adrenergic alpha-Antagonists
Adrenergic Agents
Adrenergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014