Efficacy and Safety of VA106483 in Elderly Males - Full Text View

Sponsor:	Vantia Ltd
Collaborator:	Veeda Clinical Research
Information provided by:	Vantia Ltd
ClinicalTrials.gov Identifier:	NCT00879138

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 I Phase II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Ages Eligible for Study:	65 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879138

Locations

United Kingdom
Veeda Clinical Research
Plymouth, United Kingdom

Sponsors and Collaborators

Vantia Ltd

Veeda Clinical Research

More Information

No publications provided

Study ID Numbers:	483-001
Study First Received:	February 18, 2009
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00879138 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Nocturia

ClinicalTrials.gov processed this record on February 08, 2010