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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00703703
First received: June 19, 2008
Last updated: August 1, 2012
Last verified: August 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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
Other Name: Detrol LA
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo tablet once daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703703

Locations
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
Novartis
Procter and Gamble
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00703703     History of Changes
Other Study ID Numbers: CDAR328A2414
Study First Received: June 19, 2008
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Heart rate, overactive bladder

Additional relevant MeSH terms:
Tolterodine
Darifenacin
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 16, 2014