Dose Range Finding Study of Fedovapagon in Men With Nocturia

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

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

Details

• Lead Sponsor: Vantia Ltd

Criteria

Inclusion Criteria:

• Males aged 55 or over

• History and/ or symptoms of Nocturia (2 - 5 voids per night)

• Generally well (concomitant illness / conditions well controlled)

• Serum sodium, potassium, chloride and bicarbonate within normal limits

• No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination

• Prostate specific antigen (PSA) within the normal range or not considered clinically significant

• Ability to comply with the requirements of the study

• Written informed consent.

Exclusion Criteria:

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