This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Special Survey on PD Patients With Renal Dysfunction

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

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 ]
  • Incidence of adverse drug reactions (ADRs [ Time Frame: up to 12 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures:
  • Modified Hoehn & Yahr rating scale [ Time Frame: change from baseline to week 12 ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) part III total score [ Time Frame: change from baseline to week 12 ]
  • Physician's overall judgement by medical interview into 4 grades (5 categories) [ Time Frame: week 12 ]

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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic PD with renal dysfunction from Primary Care setting.

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:

  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 identifier: NCT00613756

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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00613756     History of Changes
Other Study ID Numbers: 248.548
Study First Received: January 31, 2008
Last Updated: November 12, 2013

Additional relevant MeSH terms:
Parkinson Disease
Renal Insufficiency
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Kidney Diseases
Urologic Diseases processed this record on September 19, 2017