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Efficacy and Safety of VA106483 in Elderly Males

2014-08-27 03:23:00 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Conditions

Nocturia

Intervention

VA106483

Location

Veeda Clinical Research
Plymouth
United Kingdom

Status

Completed

Source

Vantia Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:00-0400

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PubMed Articles [30 Associated PubMed Articles listed on BioPortfolio]

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To identify the association between nocturia and obstructive sleep apnea (OSA), we compared results of polysomnography (PSG) with the presence or absence of nocturia in patients with suspected OSA.

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence-Research Society 2018.

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Medical and Biotech [MESH] Definitions

Frequent URINATION at night that interrupts sleep. It is often associated with outflow obstruction, DIABETES MELLITUS, or bladder inflammation (CYSTITIS).

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

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