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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tolterodine; Drug: Placebo; Drug: Darifenacin

• Registration Number: NCT00703703
• Lead Sponsor: Novartis

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

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-23
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Tolterodine	Tolterodine
3	Placebo	Placebo
1	Darifenacin	Darifenacin

Primary Outcome Measures

Name	Time	Method
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	7 days

Secondary Outcome Measures

Name	Time	Method
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	7 days

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Morgantown, West Virginia, United States