NCT00413790

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
162

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

12 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

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

December 19, 2006

Last Update Submit

January 14, 2008

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

Secondary Outcomes (2)

  • 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

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

2
PlaceboDRUG

Placebo tablet once daily

3

Eligibility Criteria

Age50 Years+
Sexall
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.)
  • 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 (12)

Investigative Site

Scottsdale, Arizona, 85251, United States

Location

Investigative Site

Tempe, Arizona, 85282, United States

Location

Investigative Site

San Diego, California, 92103, United States

Location

Investigative Site

Jacksonville, Florida, 32216, United States

Location

Investigative Site

Jupiter, Florida, 33458, United States

Location

Investigative Site

Overland Park, Kansas, 66215, United States

Location

Investigative Site

Madisonville, Kentucky, 42431, United States

Location

Investigative Site

Wellesley Hills, Massachusetts, 02481, United States

Location

Investigative Site

Hackensack, New Jersey, 07601, United States

Location

Investigative Site

Buffalo, New York, 14202, United States

Location

Investigative Site

Austin, Texas, 78752, United States

Location

Investigative Site

Dallas, Texas, 75235, 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 Corp.

    NPC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Study Start

November 1, 2006

Study Completion

September 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(12)