NCT00703703

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

June 19, 2008

Last Update Submit

August 1, 2012

Conditions

Healthy

Keywords

Heart rate, overactive bladder

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (3)

1

EXPERIMENTAL

Darifenacin

Drug: Darifenacin

2

ACTIVE COMPARATOR

Tolterodine

Drug: Tolterodine

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DarifenacinDRUG

Darifenacin tablets 15 mg once daily

Also known as: Enablex
1
TolterodineDRUG

Tolterodine extended release (ER) 4 mg once daily

Also known as: Detrol LA
2
PlaceboDRUG

Placebo tablet once daily

3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Investigative Site

Phoenix, Arizona, United States

Location

Investigative Site

Tempe, Arizona, United States

Location

Investigative Site

Little Rock, Arkansas, United States

Location

Investigative Site

San Diego, California, United States

Location

Investigative Site

Washington D.C., District of Columbia, United States

Location

Investigative Site

Fort Myers, Florida, United States

Location

Investigative Site

Jacksonville, Florida, United States

Location

Investigative Site

Jupiter, Florida, United States

Location

Investigative Site

Miami, Florida, United States

Location

Investigative Site

Orlando, Florida, United States

Location

Investigative Site

Overland Park, Kansas, United States

Location

Investigative Site

Topeka, Kansas, United States

Location

Investigative Site

Riverdale, Maryland, United States

Location

Investigative Site

Wellesley Hills, Massachusetts, United States

Location

Investigative Site

Springfield, Missouri, United States

Location

Investigative Site

Hackensack, New Jersey, United States

Location

Investigative Site

Burlington, North Carolina, United States

Location

Investigative Site

Greensboro, North Carolina, United States

Location

Investigative Site

Oklahoma City, Oklahoma, United States

Location

Investigative Site

Knoxville, Tennessee, United States

Location

Investigative Site

Morgantown, West Virginia, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

darifenacinTolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 23, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(21)