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Special Survey on PD Patients With Renal Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613756
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : November 13, 2013
Information provided by:
Boehringer Ingelheim

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.

Condition or disease
Parkinson Disease

Study Type : Observational
Actual Enrollment : 107 participants
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
Study Start Date : February 2004
Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 12 weeks ]
  2. Incidence of adverse drug reactions (ADRs [ Time Frame: up to 12 weeks ]
  3. Incidence of serious adverse events (SAEs) [ Time Frame: up to 12 weeks ]

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

Information from the National Library of Medicine

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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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613756

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00613756     History of Changes
Other Study ID Numbers: 248.548
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 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