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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
  Purpose
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 Intervention Phase
Healthy Drug: Darifenacin Drug: Tolterodine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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

Enrollment: 162
Study Start Date: November 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin tablets 15 mg once daily
Other Name: Enablex
Active Comparator: 2
Tolterodine
Drug: Tolterodine
Tolterodine extended release (ER) 4 mg once daily
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo tablet once daily

  Eligibility

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
Criteria

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00413790


Locations
United States, Arizona
Investigative Site
Scottsdale, Arizona, United States, 85251
Investigative Site
Tempe, Arizona, United States, 85282
United States, California
Investigative Site
San Diego, California, United States, 92103
United States, Florida
Investigative Site
Jacksonville, Florida, United States, 32216
Investigative Site
Jupiter, Florida, United States, 33458
United States, Kansas
Investigative Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Investigative Site
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
Investigative Site
Wellesley Hills, Massachusetts, United States, 02481
United States, New Jersey
Investigative Site
Hackensack, New Jersey, United States, 07601
United States, New York
Investigative Site
Buffalo, New York, United States, 14202
United States, Texas
Investigative Site
Austin, Texas, United States, 78752
Investigative Site
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Study Chair: Novartis Pharmaceuticals Corp. NPC
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00413790     History of Changes
Other Study ID Numbers: CDAR328A2413
First Submitted: December 19, 2006
First Posted: December 20, 2006
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by Novartis:
Heart rate, overactive bladder

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