Clinical trial NCT00703703: 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 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: PHASE1
Conditions: Healthy
Keywords: Heart rate, overactive bladder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2008-06-23
Enrollment: 117
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.)
* 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.

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
timeFrame: 7 days
Secondary outcomes:
measure: 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
timeFrame: 7 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Tempe
country: United States
facility: Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Washington
country: United States
facility: Investigative Site
state: District of Columbia
city: Fort Myers
country: United States
facility: Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Overland Park
country: United States
facility: Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Investigative Site
state: Kansas
city: Riverdale
country: United States
facility: Investigative Site
state: Maryland
city: Wellesley Hills
country: United States
facility: Investigative Site
state: Massachusetts
city: Springfield
country: United States
facility: Investigative Site
state: Missouri
city: Hackensack
country: United States
facility: Investigative Site
state: New Jersey
city: Burlington
country: United States
facility: Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Knoxville
country: United States
facility: Investigative Site
state: Tennessee
city: Morgantown
country: United States
facility: Investigative Site
state: West Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: