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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00795509 |
Purpose
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Bladder, Overactive |
Drug: Tolterodine tartrate |
Phase IV |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan). |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Tolterodine tartrate.
Patients taking Tolterodine tartrate.
|
Drug: Tolterodine tartrate
Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability."
|
All the patients whom an investigator prescribes the first Detrusitol® Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6121187 |
| Study First Received: | November 19, 2008 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00795509 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency (PMDA) |
|
Pseudoephedrine Urinary Bladder, Overactive Cystocele Urinary Bladder Diseases Naphazoline Signs and Symptoms Oxymetazoline |
Urologic Diseases Phenylephrine Guaifenesin Ephedrine Phenylpropanolamine Tolterodine |
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Respiratory System Agents Neurotransmitter Agents Adrenergic alpha-Agonists Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents Cholinergic Agents Pharmacologic Actions |
Adrenergic Agonists Nasal Decongestants Muscarinic Antagonists Urological Manifestations Anti-Obesity Agents Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Appetite Depressants Peripheral Nervous System Agents Central Nervous System Agents |
