Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1449 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Brief Summary

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The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

* Unexpected adverse events (especially, serious adverse events (SAEs))
* To find out the status of incidence of adverse events under actual practice
* Factors on the safety profile
* Factors on the efficacy profile

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic Parkinson's disease patients

Pramipexole

Intervention Type DRUG

Interventions

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Pramipexole

Intervention Type DRUG

Other Intervention Names

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Mirapex®

Eligibility Criteria

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Inclusion Criteria

* Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping

Exclusion Criteria

* Following patients are contraindicated.

1. Patients who are hypersensitive to MIRAPEX or its ingredients
2. Refer to the insert paper for other contraindication.
* Following patients should be carefully administered.

1. Patient with renal impairment
2. Refer to the insert paper for other precaution.

Eligible Sex

ALL

Accepts Healthy Volunteers

No