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Efficacy and Safety of VA106483 in Elderly Males

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879138
First Posted: April 9, 2009
Last Update Posted: April 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Veeda Clinical Research
Information provided by:
Vantia Ltd
  Purpose
A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

Condition Intervention Phase
Nocturia Drug: VA106483 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: A Double-Blind, Placebo-Controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Pharmacodynamic profile of VA106483

Secondary Outcome Measures:
  • Pharmacokinetic profile of VA106483
  • Safety and tolerability of VA106483

Enrollment: 27
Study Start Date: August 2008
Detailed Description:
VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.
  Eligibility

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:   No
Criteria

Inclusion Criteria:

  • Males 65 years and above with history of nocturia

Exclusion Criteria:

  • Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
  • Participation in any other clinical study within 30 days
  • Intake of non-prescription medication within 14 days
  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): NCT00879138


Locations
United Kingdom
Veeda Clinical Research
Plymouth, United Kingdom
Sponsors and Collaborators
Vantia Ltd
Veeda Clinical Research
  More Information

ClinicalTrials.gov Identifier: NCT00879138     History of Changes
Other Study ID Numbers: 483-001
First Submitted: February 18, 2009
First Posted: April 9, 2009
Last Update Posted: April 9, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms