Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2009-12-31
2010-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VA106483 1mg
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
VA106483 2mg
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
VA106483 4mg
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
Sugar pill
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Vantia Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Mira Baron
Role: PRINCIPAL_INVESTIGATOR
Rapid Medical Research, Inc.
David Beccia
Role: PRINCIPAL_INVESTIGATOR
Medical & Clinical Research Associates
Kenneth Blaze
Role: PRINCIPAL_INVESTIGATOR
South Broward Research, LLC
Mitchell Efros
Role: PRINCIPAL_INVESTIGATOR
Accumed Research Associates
Marc Gittelman
Role: PRINCIPAL_INVESTIGATOR
South Florida Medical Research
Evan Goldfischer
Role: PRINCIPAL_INVESTIGATOR
Hudson Valley Urology, PC
Elizabeth Houser
Role: PRINCIPAL_INVESTIGATOR
The Urology Team P.A.
Theodore Johnson II
Role: PRINCIPAL_INVESTIGATOR
Emory University
Steven Kester
Role: PRINCIPAL_INVESTIGATOR
Urology Center of Florida
Richard Lotenfoe
Role: PRINCIPAL_INVESTIGATOR
Discovery Clinical Trials
Earl Martin
Role: PRINCIPAL_INVESTIGATOR
Martin Diagnostic Clinic
H. David Mitcheson
Role: PRINCIPAL_INVESTIGATOR
Bay State Clinical Trials, Inc.
Chris Ng
Role: PRINCIPAL_INVESTIGATOR
Tower Urology Medical Group
Aris Nikas
Role: PRINCIPAL_INVESTIGATOR
Health Texas Research Institute
Joseph Parkhurst
Role: PRINCIPAL_INVESTIGATOR
Parkhurst Research Organization
Bruce Rankin
Role: PRINCIPAL_INVESTIGATOR
Avail Clinical Research LLC
Leah Schmidt
Role: PRINCIPAL_INVESTIGATOR
Genova Clinical Research
Howard Hezmall
Role: PRINCIPAL_INVESTIGATOR
Urology Associates of North Texas
Wilbur Wells Jnr
Role: PRINCIPAL_INVESTIGATOR
Alabama Research Center, LLC
Rafael Wurzel
Role: PRINCIPAL_INVESTIGATOR
Grove Hill Clinical Research
Locations
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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
Countries
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Other Identifiers
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483-005
Identifier Type: -
Identifier Source: org_study_id
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