- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00413790
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
January 14, 2008 updated by: Novartis
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
-
Scottsdale, Arizona, United States, 85251
- Investigative Site
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Tempe, Arizona, United States, 85282
- Investigative Site
-
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California
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San Diego, California, United States, 92103
- Investigative Site
-
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Florida
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Jacksonville, Florida, United States, 32216
- Investigative Site
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Jupiter, Florida, United States, 33458
- Investigative Site
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Kansas
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Overland Park, Kansas, United States, 66215
- Investigative Site
-
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Kentucky
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Madisonville, Kentucky, United States, 42431
- Investigative Site
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Massachusetts
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Wellesley Hills, Massachusetts, United States, 02481
- Investigative Site
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Investigative Site
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New York
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Buffalo, New York, United States, 14202
- Investigative Site
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Texas
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Austin, Texas, United States, 78752
- Investigative Site
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Dallas, Texas, United States, 75235
- Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
Placebo
|
Placebo tablet once daily
|
Experimental: 1
Darifenacin
|
Darifenacin tablets 15 mg once daily
Other Names:
|
Active Comparator: 2
Tolterodine
|
Tolterodine extended release (ER) 4 mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
December 19, 2006
First Submitted That Met QC Criteria
December 19, 2006
First Posted (Estimate)
December 20, 2006
Study Record Updates
Last Update Posted (Estimate)
January 15, 2008
Last Update Submitted That Met QC Criteria
January 14, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDAR328A2413
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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