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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Intervention(s) in this Clinical Trial

• Drug: Darifenacin
  • Darifenacin tablets 15 mg once daily
• Drug: Tolterodine
  • Tolterodine extended release (ER) 4 mg once daily
• Drug: Placebo
  • Placebo tablet once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Darifenacin
• Active Comparator: 2
  • Tolterodine
• Placebo Comparator: 3
  • Placebo

Primary Measures

• 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 Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Corp. Study Chair NPC  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00413790

Study ID Number: CDAR328A2413

ClinicalTrials.gov Identifier: NCT00413790

Health Authority: United States: Food and Drug Administration