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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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Veeda Clinical Research
Published on BioPortfolio: 2014-08-27T03:23:00-0400
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
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.
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to ...
The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic ca...
Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS ...
Nocturia is defined as awakening due to the desire to void during a period of intended sleep. The pathophysiology of nocturia is multifactorial and management remains a challenge. Herein, we provide a...
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.
Nocturia or waking at night, to urinate is a common cause of awakenings and may lead to sleep disturbance, impaired somatic health, impaired quality of life, and increased mortality. The aim of this r...
Nocturnal polyuria (NP), the most common etiology of nocturia, can be caused by various medical conditions, including cardiovascular disease, obstructive sleep apnea, renal tubular dysfunction, as wel...
Nocturia is a bothersome, multifactorial condition with many underlying causes and contributing factors. Nocturnal polyuria (NP; overproduction of urine at night) is a frequent component. The prevalen...
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.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...