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

A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330927

Enrollment

Registered

2011-04-07

Start date

2011-03-31

Completion date

2011-07-31

Last updated

2011-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hypertrophy (BPH), Nocturia

Keywords

VA106483, Nocturia, Benign Prostatic Hypertrophy, BPH, Elderly, Males, Nocturnal voids, Anti-diuretic

Brief 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.

Detailed description

VA106483 is a selective vasopressin V2-receptor (V2-receptor) agonist that is being developed for the treatment of nocturia. The antidiuretic effect of V2-receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and nocturia. Nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It is the most bothersome symptom of benign prostatic hypertrophy and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (nocturnal polyuria). Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists. The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.

Interventions

DRUGVA106483

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)

Exclusion criteria

* Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study * Any clinically significant concomitant medical disease, condition or abnormal laboratory test result * Other protocol defined eligibility criteria may apply

Design outcomes

Primary

Measure	Time frame
Change in the mean nocturnal urine volumes	20 days

Secondary

Measure	Time frame
Change in mean time to first void	20 days
Change in frequency of daytime voids	20 days
Change in mean volume of daytime voids	20 days
Change in the mean nocturnal void frequency	20 days
Change in mean daytime urine osmolality	20 days
Change in mean voided volumes	20 days
Change in mean nocturnal urine osmolality	20 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026