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

August 1, 2012 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Investigative Site
      • Tempe, Arizona, United States
        • Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Investigative Site
    • California
      • San Diego, California, United States
        • Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Investigative Site
    • Florida
      • 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
        • Investigative Site
    • Kansas
      • Overland Park, Kansas, United States
        • Investigative Site
      • Topeka, Kansas, United States
        • Investigative Site
    • Maryland
      • Riverdale, Maryland, United States
        • Investigative Site
    • Massachusetts
      • Wellesley Hills, Massachusetts, United States
        • Investigative Site
    • Missouri
      • Springfield, Missouri, United States
        • Investigative Site
    • New Jersey
      • Hackensack, New Jersey, United States
        • Investigative Site
    • North Carolina
      • Burlington, North Carolina, United States
        • Investigative Site
      • Greensboro, North Carolina, United States
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Investigative Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Placebo
Drug: Placebo
Placebo tablet once daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDAR328A2414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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