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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-09-30

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

Darifenacin tablets 15 mg once daily

2

Tolterodine

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

Tolterodine extended release (ER) 4 mg once daily

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet once daily

Interventions

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Darifenacin

Darifenacin tablets 15 mg once daily

Intervention Type DRUG

Tolterodine

Tolterodine extended release (ER) 4 mg once daily

Intervention Type DRUG

Placebo

Placebo tablet once daily

Intervention Type DRUG

Other Intervention Names

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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.)
* 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No