Dose Range Finding Study of Fedovapagon in Men With Nocturia

Completed · Phase 2 · Has a placebo group

Conditions studied: Nocturia

In brief

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.

Key facts

Study ID

NCT01656239

Run by

Vantia Ltd

People needed

358

Starts

2012-08-01

Expected to finish

2013-09-01

Last updated by the study team

2014-06-20

Who can join

Age: 55 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Vantia Investigative Center — Huntsville, Alabama, United States
• Vantia Investigative Center — Mobile, Alabama, United States
• Vantia Investigative Center — Glendale, Arizona, United States
• Vantia Investigative Center — Tucson, Arizona, United States
• Vantia Investigative Center — Anaheim, California, United States
• Vantia Investigative Center — Long Beach, California, United States
• Vantia Investigative Center — San Diego, California, United States
• Vantia Investigative Center — Denver, Colorado, United States
• Vantia Investigative Center — Englewood, Colorado, United States
• Vantia Investigative Center — Milford, Connecticut, United States
• Vantia Investigative Center — Aventura, Florida, United States
• Vantia Investigative Center — Clearwater, Florida, United States
• Vantia Investigative Center — Daytona Beach, Florida, United States
• Vantia Investigative Center — DeLand, Florida, United States
• Vantia Investigative Center — Naples, Florida, United States
• Vantia Investigative Center — Ocala, Florida, United States
• Vantia Investigative Center — St. Petersburg, Florida, United States
• Vantia Investigative Center — Tampa, Florida, United States
• Vantia Investigative Center — Coeur d'Alene, Idaho, United States
• Vantia Investigative Center — Meridian, Idaho, United States
• Vantia Investigative Center — Chicago, Illinois, United States
• Vantia Investigative Center — Evansville, Indiana, United States
• Vantia Investigative Center — Jeffersonville, Indiana, United States
• Vantia Investigative Center — Paducah, Kentucky, United States
• Vantia Investigative Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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