Post Marketing Surveillance And Special Surveillance for... | NCT02248168

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

NCT02248168

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

1,449Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Pramipexole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Sep 22, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,449Actual

Label	Type	Description	Intervention Names
Idiopathic Parkinson's disease patients			Drug: Pramipexole

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole	Drug		Idiopathic Parkinson's disease patients	Mirapex®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)	Tremor at rest, Rigidity, Body bradykinesia and hypokinesia	up to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		up to 4 weeks
Global Assessment of efficacy by investigator on 3-point scale		after 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with idiopathic Parkinson's disease

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077487	Pramipexole

Ancestor Terms

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided