Special Survey on PD Patients With Renal Dysfunction

November 12, 2013 updated by: Boehringer Ingelheim

Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Azumino, Japan
        • Boehringer Ingelheim Investigational Site
      • Chuo, Japan
        • Boehringer Ingelheim Investigational Site
      • Eiheiji, Japan
        • Boehringer Ingelheim Investigational Site
      • Fuji, Japan
        • Boehringer Ingelheim Investigational Site
      • Fujinomiya, Japan
        • Boehringer Ingelheim Investigational Site
      • Fujisaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukui, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site
      • Hachioji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site
      • Ichinoseki, Japan
        • Boehringer Ingelheim Investigational Site
      • Iga, Japan
        • Boehringer Ingelheim Investigational Site
      • Iida, Japan
        • Boehringer Ingelheim Investigational Site
      • Ina, Japan
        • Boehringer Ingelheim Investigational Site
      • Inazawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Isehara, Japan
        • Boehringer Ingelheim Investigational Site
      • Isezaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Iwamizawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site
      • Kajiki, Japan
        • Boehringer Ingelheim Investigational Site
      • Kanoya, Japan
        • Boehringer Ingelheim Investigational Site
      • Kashiwazaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawagoe, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Koga, Japan
        • Boehringer Ingelheim Investigational Site
      • Komae, Japan
        • Boehringer Ingelheim Investigational Site
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site
      • Koshigaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Kurashiki, Japan
        • Boehringer Ingelheim Investigational Site
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Marugame, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsudo, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Miki, Japan
        • Boehringer Ingelheim Investigational Site
      • Mito, Japan
        • Boehringer Ingelheim Investigational Site
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Miyoshi, Japan
        • Boehringer Ingelheim Investigational Site
      • Mooka, Japan
        • Boehringer Ingelheim Investigational Site
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site
      • Moroyama, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagahama, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagakute, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagasaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site
      • Nanao, Japan
        • Boehringer Ingelheim Investigational Site
      • Nangoku, Japan
        • Boehringer Ingelheim Investigational Site
      • Narita, Japan
        • Boehringer Ingelheim Investigational Site
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site
      • Ogaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site
      • Okawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site
      • Okinawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Onga, Japan
        • Boehringer Ingelheim Investigational Site
      • Onojo, Japan
        • Boehringer Ingelheim Investigational Site
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Oshu, Japan
        • Boehringer Ingelheim Investigational Site
      • Sado, Japan
        • Boehringer Ingelheim Investigational Site
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site
      • Sanjo, Japan
        • Boehringer Ingelheim Investigational Site
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site
      • Sekigahara, Japan
        • Boehringer Ingelheim Investigational Site
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site
      • Shingu, Japan
        • Boehringer Ingelheim Investigational Site
      • Shunan, Japan
        • Boehringer Ingelheim Investigational Site
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site
      • Takasago, Japan
        • Boehringer Ingelheim Investigational Site
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site
      • Togitsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Adachi-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Chiyoda-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Setagaya-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shibuya-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Suginami-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site
      • Toyoake, Japan
        • Boehringer Ingelheim Investigational Site
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site
      • Uki, Japan
        • Boehringer Ingelheim Investigational Site
      • Wakayama, Japan
        • Boehringer Ingelheim Investigational Site
      • Yamagata, Japan
        • Boehringer Ingelheim Investigational Site
      • Yamaguchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site
      • Yokosuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Yonago, Japan
        • Boehringer Ingelheim Investigational Site
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Yufu, Japan
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Hoehn & Yahr rating scale
Time Frame: change from baseline to week 12
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
change from baseline to week 12
Physician's overall judgement by medical interview into 4 grades (5 categories)
Time Frame: week 12
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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