Efficacy Study of VA106483 in Males With Nocturia.

Summary

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

Conditions

• Nocturia

Interventions

DRUG

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

Sponsors & Collaborators

• Vantia Ltd

  lead INDUSTRY

Principal Investigators

• Mira Baron · Rapid Medical Research, Inc.

• David Beccia · Medical & Clinical Research Associates

• Kenneth Blaze · South Broward Research, LLC

• Mitchell Efros · Accumed Research Associates

• Marc Gittelman · South Florida Medical Research

• Evan Goldfischer · Hudson Valley Urology, PC

• Elizabeth Houser · The Urology Team P.A.

• Theodore Johnson II · Emory University

• Steven Kester · Urology Center of Florida

• Richard Lotenfoe · Discovery Clinical Trials

• Earl Martin · Martin Diagnostic Clinic

• H. David Mitcheson · Bay State Clinical Trials, Inc.

• Chris Ng · Tower Urology Medical Group

• Aris Nikas · Health Texas Research Institute

• Joseph Parkhurst · Parkhurst Research Organization

• Bruce Rankin · Avail Clinical Research LLC

• Leah Schmidt · Genova Clinical Research

• Howard Hezmall · Urology Associates of North Texas

• Wilbur Wells Jnr · Alabama Research Center, LLC

• Rafael Wurzel · Grove Hill Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2010-07-31

Completion

2010-08-31

Countries

• United States

Study Locations