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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Healthy

Treatments

Drug: Darifenacin
Drug: Tolterodine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413790
CDAR328A2413

Details and patient eligibility

About

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

Enrollment

162 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

162 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
Darifenacin
Treatment:
Drug: Darifenacin
2
Active Comparator group
Description:
Tolterodine
Treatment:
Drug: Tolterodine
3
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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