Efficacy Study of VA106483 in Males With Nocturia.

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vantia Ltd

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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