NCT01038843

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	VA106483	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

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-12-24
• Last updated: 2014-06-20

Locations

19 sites across 1 country: United States