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Efficacy and Safety of VA106483 in Elderly Males

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ClinicalTrials.gov Identifier: NCT00879138
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
Vantia Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Nocturia Drug: VA106483 Drug: Sugar pill Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Actual Study Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Placebo Comparator: Sugar pill Drug: Sugar pill
Experimental: VA106483 2 mg Drug: VA106483
Experimental: VA106483 4 mg Drug: VA106483
Experimental: VA106483 8 mg Drug: VA106483



Primary Outcome Measures :
  1. Pharmacodynamic profile of VA106483

Secondary Outcome Measures :
  1. Pharmacokinetic profile of VA106483
  2. Safety and tolerability of VA106483


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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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

Responsible Party: Vantia Ltd
ClinicalTrials.gov Identifier: NCT00879138     History of Changes
Other Study ID Numbers: 483-001
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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