A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Novartis718 enrolled

Overview

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

718

Conditions

Overactive Bladder Syndrome

Interventions

DarifenacinDRUG

Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with overactive bladder who completed a previous darifenacin short-term trial. * Patients capable of independent toileting and able of independently completing the patient diary. Exclusion Criteria: * Patients in whom the use of anticholinergic drugs was contraindicated * Evidence of severe liver disease * Patients with other clinically significant urinary or gynecological conditions Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.

Secondary Outcomes

Long term efficacy on the symptoms of overactive bladder

King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),

Data from ClinicalTrials.gov

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