Efficacy and Safety of VA106483 in Elderly Males

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vantia Ltd
• Collaborator: Veeda Clinical Research

Criteria

Inclusion Criteria:

• Males 65 years and above with history of nocturia

Exclusion Criteria:

• Any clinically significant concomitant medical disease, condition or abnormal laboratory test result

• Participation in any other clinical study within 30 days

• Intake of non-prescription medication within 14 days