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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413790
First Posted: December 20, 2006
Last Update Posted: January 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Novartis
December 19, 2006
December 20, 2006
January 15, 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 ClinicalTrials.gov 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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
    Darifenacin
    Intervention: Drug: Darifenacin
  • Active Comparator: 2
    Tolterodine
    Intervention: Drug: Tolterodine
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
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

Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00413790
CDAR328A2413
Not Provided
Not Provided
Not Provided
External Affairs, Novartis
Novartis
Procter and Gamble
Study Chair: Novartis Pharmaceuticals Corp. NPC
Novartis
January 2008

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