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

• Status: Completed
• Trial end date: 2008-10-01
• 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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.)

• 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