Special Survey on PD Patients With Renal Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00613756
First received: January 31, 2008
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions (ADRs [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Hoehn & Yahr rating scale [ Time Frame: change from baseline to week 12 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) part III total score [ Time Frame: change from baseline to week 12 ] [ Designated as safety issue: No ]
  • Physician's overall judgement by medical interview into 4 grades (5 categories) [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: February 2004
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613756

  Show 98 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00613756     History of Changes
Other Study ID Numbers: 248.548
Study First Received: January 31, 2008
Last Updated: November 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014