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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Darifenacin (Drug); Tolterodine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corp., Study Chair, Affiliation: NPC


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

Clinical Details

Official title: A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Pharmacologic Effects of a 7-Day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7

Secondary outcome:

Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7

Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Investigative Site, Scottsdale, Arizona 85251, United States

Investigative Site, Tempe, Arizona 85282, United States

Investigative Site, San Diego, California 92103, United States

Investigative Site, Jacksonville, Florida 32216, United States

Investigative Site, Jupiter, Florida 33458, United States

Investigative Site, Overland Park, Kansas 66215, United States

Investigative Site, Madisonville, Kentucky 42431, United States

Investigative Site, Wellesley Hills, Massachusetts 02481, United States

Investigative Site, Hackensack, New Jersey 07601, United States

Investigative Site, Buffalo, New York 14202, United States

Investigative Site, Austin, Texas 78752, United States

Investigative Site, Dallas, Texas 75235, United States

Additional Information

Starting date: November 2006
Last updated: January 14, 2008

Page last updated: August 23, 2015

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