Status:
COMPLETED
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Procter and Gamble
Conditions:
Healthy
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00413790
Start Date
November 1 2006
End Date
September 1 2007
Last Update
January 15 2008
Active Locations (12)
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1
Investigative Site
Scottsdale, Arizona, United States, 85251
2
Investigative Site
Tempe, Arizona, United States, 85282
3
Investigative Site
San Diego, California, United States, 92103
4
Investigative Site
Jacksonville, Florida, United States, 32216