MedDataX Logo

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

NCT ID: NCT00703703

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heart rate, overactive bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

Darifenacin tablets 15 mg once daily

2

Tolterodine

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

Tolterodine extended release (ER) 4 mg once daily

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Darifenacin

Darifenacin tablets 15 mg once daily

Intervention Type DRUG

Tolterodine

Tolterodine extended release (ER) 4 mg once daily

Intervention Type DRUG

Placebo

Placebo tablet once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enablex Detrol LA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigative Site

Phoenix, Arizona, United States

Site Status

Investigative Site

Tempe, Arizona, United States

Site Status

Investigative Site

Little Rock, Arkansas, United States

Site Status

Investigative Site

San Diego, California, United States

Site Status

Investigative Site

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

Site Status

Investigative Site

Fort Myers, Florida, United States

Site Status

Investigative Site

Jacksonville, Florida, United States

Site Status

Investigative Site

Jupiter, Florida, United States

Site Status

Investigative Site

Miami, Florida, United States

Site Status

Investigative Site

Orlando, Florida, United States

Site Status

Investigative Site

Overland Park, Kansas, United States

Site Status

Investigative Site

Topeka, Kansas, United States

Site Status

Investigative Site

Riverdale, Maryland, United States

Site Status

Investigative Site

Wellesley Hills, Massachusetts, United States

Site Status

Investigative Site

Springfield, Missouri, United States

Site Status

Investigative Site

Hackensack, New Jersey, United States

Site Status

Investigative Site

Burlington, North Carolina, United States

Site Status

Investigative Site

Greensboro, North Carolina, United States

Site Status

Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Investigative Site

Knoxville, Tennessee, United States

Site Status

Investigative Site

Morgantown, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDAR328A2414

Identifier Type: -

Identifier Source: org_study_id