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Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

NCT01330927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-08-02

No results posted yet for this study

Summary

The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.

Conditions

  • Nocturia
  • Benign Prostatic Hypertrophy (BPH)

Interventions

DRUG

VA106483

Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above

Sponsors & Collaborators

  • Vantia Ltd

    lead INDUSTRY

Principal Investigators

  • Georg Golor, PD Dr. med. · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330927 on ClinicalTrials.gov