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

Novartis

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Darifenacin; Drug: Tolterodine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413790

CDAR328A2413

Details and patient eligibility

About

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

Enrollment: 162 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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162 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Darifenacin

Treatment:

Drug: Darifenacin

2

Active Comparator group

Description:

Tolterodine

Treatment:

Drug: Tolterodine

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo