Clinical trial NCT00413790: Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Heart rate, overactive bladder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2006-12-20
Enrollment: 162
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.)
* 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

Primary outcomes:
measure: 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:
measure: Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7
measure: Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigative Site
state: Arizona
city: Tempe
country: United States
facility: Investigative Site
state: Arizona
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Investigative Site
state: Florida
city: Overland Park
country: United States
facility: Investigative Site
state: Kansas
city: Madisonville
country: United States
facility: Investigative Site
state: Kentucky
city: Wellesley Hills
country: United States
facility: Investigative Site
state: Massachusetts
city: Hackensack
country: United States
facility: Investigative Site
state: New Jersey
city: Buffalo
country: United States
facility: Investigative Site
state: New York
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Dallas
country: United States
facility: Investigative Site
state: Texas
Study officials:
affiliation: NPC
name: Novartis Pharmaceuticals Corp.
role: STUDY_CHAIR
References: