Efficacy Study of VA106483 in Males With Nocturia.

Completed · Phase 2 · Has a placebo group

Conditions studied: Nocturia

In brief

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Key facts

Study ID

NCT01038843

Run by

Vantia Ltd

People needed

152

Starts

2009-12-01

Expected to finish

2010-08-01

Last updated by the study team

2014-06-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Research Center, LLC — Birmingham, Alabama, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Tower Urology Medical Group — Los Angeles, California, United States
• Grove Hill Clinical Research — New Britian, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Discovery Clinical Trials — Celebration, Florida, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• Urology Center of Florida — Hialeah, Florida, United States
• South Broward Research, LLC — Pembroke Pines, Florida, United States
• Bay State Clinical Trials, Inc. — Watertown, Massachusetts, United States
• Medical & Clinical Research Associates — Bay Shore, New York, United States
• Accumed Research Associates — Garden City, New York, United States
• Hudson Valley Urology, PC — Poughkeepsie, New York, United States
• Rapid Medical Research, Inc. — Clevland, Ohio, United States
• Parkhurst Research Organization — Bethany, Oklahoma, United States
• Urology Associates of North Texas — Arlington, Texas, United States
• The Urology Team P.A. — Austin, Texas, United States
• Health Texas Research Institute — San Antonio, Texas, United States
• Martin Diagnostic Clinic — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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