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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00703703

Run by

Novartis

People needed

117

Starts

2008-05-01

Expected to finish

2008-10-01

Last updated by the study team

2012-08-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — San Diego, California, United States
• Investigative Site — Washington D.C., District of Columbia, United States
• Investigative Site — Fort Myers, Florida, United States
• Investigative Site — Jacksonville, Florida, United States
• Investigative Site — Jupiter, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Orlando, Florida, United States
• Investigative Site — Overland Park, Kansas, United States
• Investigative Site — Topeka, Kansas, United States
• Investigative Site — Riverdale, Maryland, United States
• Investigative Site — Wellesley Hills, Massachusetts, United States
• Investigative Site — Springfield, Missouri, United States
• Investigative Site — Hackensack, New Jersey, United States
• Investigative Site — Burlington, North Carolina, United States
• Investigative Site — Greensboro, North Carolina, United States
• Investigative Site — Oklahoma City, Oklahoma, United States
• Investigative Site — Knoxville, Tennessee, United States
• Investigative Site — Morgantown, West Virginia, United States
• Investigative Site — Phoenix, Arizona, United States
• Investigative Site — Tempe, Arizona, United States
• Investigative Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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