Overview

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

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Details
Lead Sponsor:
Novartis
Collaborator:
Procter and Gamble
Treatments:
Darifenacin
Tolterodine Tartrate
Criteria
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