Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Study Overview
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Brief Summary
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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

Official Title
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A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older

Conditions
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Healthy

Intervention / Treatment
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* Drug: Darifenacin
* Drug: Tolterodine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin tablets 15 mg once daily<br>* Other names: Enablex;|
| Active Comparator: 2<br>Tolterodine | Drug: Tolterodine<br>* Tolterodine extended release (ER) 4 mg once daily<br>* Other names: Detrol LA;|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo tablet once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rate, overactive bladder