Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

This study has been completed.
Procter and Gamble
Information provided by:
Novartis Identifier:
First received: December 19, 2006
Last updated: January 14, 2008
Last verified: January 2008

December 19, 2006
January 14, 2008
November 2006
Not Provided
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
Same as current
Complete list of historical versions of study NCT00413790 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
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

Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Drug: Darifenacin
    Darifenacin tablets 15 mg once daily
    Other Name: Enablex
  • Drug: Tolterodine
    Tolterodine extended release (ER) 4 mg once daily
  • Drug: Placebo
    Placebo tablet once daily
  • Experimental: 1
    Intervention: Drug: Darifenacin
  • Active Comparator: 2
    Intervention: Drug: Tolterodine
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
Not Provided

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

50 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
External Affairs, Novartis
Procter and Gamble
Study Chair: Novartis Pharmaceuticals Corp. NPC
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP