Healthy
Conditions
Keywords
Heart rate, overactive bladder
Brief summary
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
Interventions
DRUGDarifenacin
Darifenacin tablets 15 mg once daily
DRUGTolterodine
Tolterodine extended release (ER) 4 mg once daily
DRUGPlacebo
Placebo tablet once daily
Sponsors
Procter and Gamble
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females ≥ 50 years * Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2
Exclusion criteria
* Known or suspected allergy to tolterodine ER or darifenacin or their components * Subjects with irregular day and night patterns such as night shift workers * Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.) * Medication with potential known to affect heart rate * History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin * Pregnant or nursing women * Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7 | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7 | 7 days |
Countries
United States
Outcome results
None listed