Efficacy Study of VA106483 in Males With Nocturia.

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: VA106483


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VA106483 1mg<br> | Drug: VA106483<br>* 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<br>|
| Experimental: VA106483 2mg<br> | Drug: VA106483<br>* 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<br>|
| Experimental: VA106483 4mg<br> | Drug: VA106483<br>* 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<br>|
| Placebo Comparator: Sugar pill<br> | Drug: VA106483<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean number of nocturnal voids per night |  | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean duration of first sleep period |  | 70 days | 
| Change in nocturia-related quality of life |  | 70 days | 
| Incidence and frequency of adverse events |  | 70 days | 
| Frequency of hyponatraemia |  | 70 days | 
| Change from baseline in safety laboratory parameters |  | 70 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia