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 1
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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
Clinical Details
Official title: A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess 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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Investigative Site, Phoenix, Arizona, United States
Investigative Site, Tempe, Arizona, United States
Investigative Site, Little Rock, Arkansas, United States
Investigative Site, San Diego, California, United States
Investigative Site, Washington, 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
Additional Information
Starting date: May 2008
Last updated: August 1, 2012
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