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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00147654 |
Purpose
The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence |
Drug: Tolterodine ER 4 mg QD Drug: Tamsulosin 0.4 mg QD |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction |
| Estimated Enrollment: | 830 |
| Study Start Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 96 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | A6121120 |
| Study First Received: | September 2, 2005 |
| Last Updated: | January 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00147654 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Urinary Bladder, Overactive Neurotransmitter Agents Cystocele Cholinergic Antagonists Adrenergic Agents Urination Disorders Urinary Bladder Diseases Adrenergic alpha-Antagonists Cholinergic Agents |
Muscarinic Antagonists Signs and Symptoms Urologic Diseases Tamsulosin Adrenergic Antagonists Urinary Incontinence Urinary Bladder Neck Obstruction Urinary Incontinence, Urge Tolterodine |
|
Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Urination Disorders Antineoplastic Agents Physiological Effects of Drugs Urinary Bladder Diseases Urethral Obstruction Adrenergic alpha-Antagonists Cholinergic Agents Pharmacologic Actions |
Muscarinic Antagonists Urological Manifestations Signs and Symptoms Urologic Diseases Therapeutic Uses Tamsulosin Urethral Diseases Adrenergic Antagonists Urinary Bladder Neck Obstruction Urinary Incontinence Tolterodine |