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

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Pramipexole

Study type: Observational

Funder types: Industry

Identifiers

NCT02248168

248.599

Details and patient eligibility

About

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

Enrollment: 1,449 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,449 participants in 1 patient group

Idiopathic Parkinson's disease patients

Treatment:

Drug: Pramipexole