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:
PHASE1
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.)
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00703703
Start Date
May 1 2008
End Date
October 1 2008
Last Update
August 2 2012
Active Locations (21)
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1
Investigative Site
Phoenix, Arizona, United States
2
Investigative Site
Tempe, Arizona, United States
3
Investigative Site
Little Rock, Arkansas, United States
4
Investigative Site
San Diego, California, United States