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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00703703
Collaborator
Procter and Gamble (Industry)
117
Enrollment
21
Locations
3
Arms
5
Duration (Months)
5.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 1, 2008
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Darifenacin

Drug: Darifenacin
Darifenacin tablets 15 mg once daily
Other Names:
  • Enablex

    		•
    Active Comparator: 2

    Tolterodine

    Drug: Tolterodine
    Tolterodine extended release (ER) 4 mg once daily
    Other Names:
  • Detrol LA

    		•
    Placebo Comparator: 3

    Placebo

    Drug: Placebo
    Placebo tablet once daily

    Outcome Measures

    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 [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 [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigative Site Phoenix Arizona United States
    2 Investigative Site Tempe Arizona United States
    3 Investigative Site Little Rock Arkansas United States
    4 Investigative Site San Diego California United States
    5 Investigative Site Washington District of Columbia United States
    6 Investigative Site Fort Myers Florida United States
    7 Investigative Site Jacksonville Florida United States
    8 Investigative Site Jupiter Florida United States
    9 Investigative Site Miami Florida United States
    10 Investigative Site Orlando Florida United States
    11 Investigative Site Overland Park Kansas United States
    12 Investigative Site Topeka Kansas United States
    13 Investigative Site Riverdale Maryland United States
    14 Investigative Site Wellesley Hills Massachusetts United States
    15 Investigative Site Springfield Missouri United States
    16 Investigative Site Hackensack New Jersey United States
    17 Investigative Site Burlington North Carolina United States
    18 Investigative Site Greensboro North Carolina United States
    19 Investigative Site Oklahoma City Oklahoma United States
    20 Investigative Site Knoxville Tennessee United States
    21 Investigative Site Morgantown West Virginia United States

    Sponsors and Collaborators

    • Novartis
    • Procter and Gamble

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00703703
    Other Study ID Numbers:
    • CDAR328A2414
    First Posted:
    Jun 23, 2008
    Last Update Posted:
    Aug 2, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Novartis
    Heart rate, overactive bladder
    Additional relevant MeSH terms:
    Tolterodine Tartrate
    Darifenacin

    Study Results

    No Results Posted as of Aug 2, 2012