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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above
Alabama Research Center, LLC
Birmingham, Alabama, United States
Genova Clinical Research
Tucson, Arizona, United States
Change in the mean number of nocturnal voids per night
Time frame: 70 days
Mean duration of first sleep period
Time frame: 70 days
Change in nocturia-related quality of life
Time frame: 70 days
Incidence and frequency of adverse events
Time frame: 70 days
Frequency of hyponatraemia
Time frame: 70 days
Change from baseline in safety laboratory parameters
Time frame: 70 days
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