SUMMARY
Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist.
Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see
CLINICAL STUDIES
].
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NEWS HIGHLIGHTS
Published Studies Related to Tolterodine Extended Release (Tolterodine)
Comparison of fesoterodine and tolterodine extended release for the treatment of
overactive bladder: a head-to-head placebo-controlled trial. [2010] of patients with an overactive bladder (OAB)... CONCLUSION: In patients with OAB, fesoterodine 8 mg showed superior efficacy over
Tolterodine extended release is well tolerated in older subjects. [2009] in older subjects with overactive bladder (OAB)... CONCLUSION: The nature and frequency of AEs associated with tolterodine ER
Effect of tolterodine on gastrointestinal transit and bowel habits in healthy
subjects. [2008] Clinical trials and observations suggest that constipation is an uncommon side
effect of treating overactive bladder with the muscarinic receptor antagonist
tolterodine. Because muscarinic antagonism inhibits gastrointestinal motor
activity, we evaluated the effects of tolterodine on bowel habits,
gastrointestinal and colonic transit in healthy subjects...
The clinical efficacy of tolterodine extended-release is maintained for 24 h in
patients with overactive bladder. [2007] patients with overactive bladder (OAB) and urgency urinary incontinence (UUI)... CONCLUSIONS: These results indicate that tolterodine-ER maintained clinical
Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms
and overactive bladder: a randomized controlled trial. [2006] bladder and benign prostatic hyperplasia... CONCLUSIONS: These results suggest that treatment with tolterodine ER plus
Clinical Trials Related to Tolterodine Extended Release (Tolterodine)
Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) [Completed]
The objective of this surveillance is to collect information about 1) adverse drug reaction
not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of
adverse drug reactions in this surveillance, and 3) factors considered to affect the safety
and/or efficacy of this drug.
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) [Completed]
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride
given for 18 months, including a 1-year double-blind randomized co-administration with
either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS)
including urgency and frequency, with or without urgency urinary incontinence (i. e.,
overactive bladder (OAB) symptoms).
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects [Completed]
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
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine [Completed]
To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects
on the pharmacokinetics (PK) of tolterodine and its metabolites.
In addition, the safety of these products will be assessed.
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause. [Terminated]
This study is being done to compare frequency of urination during the night when women take
tolterodine tablets vs. when they take placebo tablets.
We will also measure whether between these two treatment conditions there are any
differences in women's sleep, mood and performance on cognitive tests.
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