Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

Inclusion Criteria: * Written informed consent prior to performance of any trial-related activity * Man ≥20 years of age * Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1 * ≥2 nocturnal voids at the end of screening period prior to Visit 2 * Nocturnal polyuria at the end of screening period prior to Visit 2 * Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2 * Has given agreement about contraception during the trial Exclusion Criteria: * Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2 * History or evidence of significant obstructive sleep apnoea * History or diagnosis of any of the following urological diseases at Visit 1: * Interstitial cystitis or bladder pain disorder * Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and: * Urinary flow \<5 mL/s or * Post-void residual volume \>150 mL * Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history * Chronic pelvic pain syndrome * Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1 * Symptoms of severe over-active bladder (OAB): * Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1 * Defined a…