A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY IN EUROPE / LATIN AMERICA, CANADA TO EVALUATE THE EFFECT OF TOLTERODINE FOR PROLONGED RELEASE ON NICTURIA IN PATIENTS WITH HYPERACTIVE BLADDER SYMPTOMS (VHA)

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2002年7月11日最近更新: 2023年9月4日

试验速览

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•1. Male or female patients> 18 years of age.
•2. Urinary frequency of> 8 voids / 24 hours and urgency with or without urge incontinence.
•3. That an average of> 2.5 micturitions occur during the planned sleep cycle, defined as from the moment in which the patient intends to fall asleep until the moment in which the patient intends to wake up.
•4. An average evacuated night volume less than 35% of the total volume eliminated in 24 hours.
•5. Symptoms of overactive bladder including urge incontinence, urgency and / or urinary frequency for> 6 months.
•6. Ability and willingness to correctly complete the micturition journals.
•7. Ability to understand and sign the informed consent form after a full discussion of the research, nature of the treatment and its risks and benefits.

•1. Significant effort incontinence as determined by the investigator through a cough test according to Appendix 2.
•2. An average evacuated volume of> 200 ml per urination as verified in the urination diary before the baseline visit.
•3. Total daily urine production of> 3000 ml, as verified in the journal of
•urination before the baseline visit.
•4. Any condition that, in the opinion of the investigator, makes the patient inadequate, or with contraindications, for inclusion (eg, uncontrolled narrow-angle glaucoma, urinary retention, or gastric retention).
•5. Patients with conduction, fi ction or heart rate.

发起方

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,