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

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. Identifier: NCT00703703
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : August 2, 2012
Procter and Gamble
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Darifenacin Drug: Tolterodine Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess 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
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Darifenacin
Darifenacin tablets 15 mg once daily
Other Name: Enablex
Active Comparator: 2
Drug: Tolterodine
Tolterodine extended release (ER) 4 mg once daily
Other Name: Detrol LA
Placebo Comparator: 3
Drug: Placebo
Placebo tablet once daily

Primary Outcome Measures :
  1. 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 [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703703

United States, Arizona
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Tempe, Arizona, United States
United States, Arkansas
Investigative Site
Little Rock, Arkansas, United States
United States, California
Investigative Site
San Diego, California, United States
United States, District of Columbia
Investigative Site
Washington, District of Columbia, United States
United States, Florida
Investigative Site
Fort Myers, Florida, United States
Investigative Site
Jacksonville, Florida, United States
Investigative Site
Jupiter, Florida, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Orlando, Florida, United States
United States, Kansas
Investigative Site
Overland Park, Kansas, United States
Investigative Site
Topeka, Kansas, United States
United States, Maryland
Investigative Site
Riverdale, Maryland, United States
United States, Massachusetts
Investigative Site
Wellesley Hills, Massachusetts, United States
United States, Missouri
Investigative Site
Springfield, Missouri, United States
United States, New Jersey
Investigative Site
Hackensack, New Jersey, United States
United States, North Carolina
Investigative Site
Burlington, North Carolina, United States
Investigative Site
Greensboro, North Carolina, United States
United States, Oklahoma
Investigative Site
Oklahoma City, Oklahoma, United States
United States, Tennessee
Investigative Site
Knoxville, Tennessee, United States
United States, West Virginia
Investigative Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Procter and Gamble
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Identifier: NCT00703703     History of Changes
Other Study ID Numbers: CDAR328A2414
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by Novartis:
Heart rate, overactive bladder

Additional relevant MeSH terms:
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents