Special Survey on PD Patients With Renal Dysfunction | NCT00613756

Status Module

Record Verification Date

Nov 2013

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

Feb 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Not provided

First Submitted Date

Jan 31, 2008

First Submission Date that Met QC Criteria

Feb 12, 2008

First Posted Date

Feb 13, 2008Estimated

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

Nov 12, 2013

Last Update Posted Date

Nov 13, 2013Estimated

Description Module

Brief Summary

The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.

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

107Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events		up to 12 weeks
Incidence of adverse drug reactions (ADRs		up to 12 weeks
Incidence of serious adverse events (SAEs)		up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Modified Hoehn & Yahr rating scale		change from baseline to week 12
Unified Parkinson's Disease Rating Scale (UPDRS) part III total score		change from baseline to week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =<70mL/min or whose renal dysfunction was determined by the physician

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with idiopathic PD with renal dysfunction from Primary Care setting.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Asahikawa			Japan
Boehringer Ingelheim Investigational Site

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases