Efficacy Study of VA106483 in Males With Nocturia.

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.

The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.

Inclusion Criteria:

• Male subjects aged ≥18 years (no upper limit) with nocturia
• Generally well (concomitant illness/conditions well controlled)
• Serum sodium within the normal limits
• Normal or not clinically significant prostate specific antigen levels
• Able to comply with the requirements of the study
• Provide written informed consent

Exclusion Criteria:

• Prostatic cancer
• Signs or symptoms of heart failure
• Peripheral pitting oedema extending ≥10 cm above the ankle
• Palpable bladder or pelvic mass on abdominal examination
• Enuresis or night-time incontinence
• Excessive nocturnal void frequency
• Sleep disorders
• Diabetes insipidus or uncontrolled diabetes mellitus
• Presence of blood or glucose in the urine on urinalysis that is clinically significant
• Urinary tract infection
• Polydipsia
• Syndrome of inappropriate antidiuretic hormone secretion
• Body mass index ≥35
• High calcium levels or low potassium levels
• Other protocol defined eligibility criteria may apply