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

Tracking Information

First Received Date ^ICMJE

December 19, 2006

Last Updated Date

January 14, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00413790 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the 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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Darifenacin
Drug: Tolterodine
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Darifenacin
Active Comparator: Tolterodine
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

162

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.)
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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00413790

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CDAR328A2413

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Procter and Gamble

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals Corp.

NPC

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP