NCT00613756

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

98 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

4.6 years

First QC Date

January 31, 2008

Last Update Submit

November 12, 2013

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • 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 (3)

  • 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

  • Physician's overall judgement by medical interview into 4 grades (5 categories)

    week 12

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (98)

Boehringer Ingelheim Investigational Site

Asahikawa, Japan

Location

Boehringer Ingelheim Investigational Site

Azumino, Japan

Location

Boehringer Ingelheim Investigational Site

Chūō, Japan

Location

Boehringer Ingelheim Investigational Site

Fuji, Japan

Location

Boehringer Ingelheim Investigational Site

Fujinomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Fujisaki, Japan

Location

Boehringer Ingelheim Investigational Site

Fukaya, Japan

Location

Boehringer Ingelheim Investigational Site

Fukui, Japan

Location

Boehringer Ingelheim Investigational Site

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site

Gifu, Japan

Location

Boehringer Ingelheim Investigational Site

Hachiōji, Japan

Location

Boehringer Ingelheim Investigational Site

Hamamatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site

Ichinoseki, Japan

Location

Boehringer Ingelheim Investigational Site

Iga, Japan

Location

Boehringer Ingelheim Investigational Site

Iida, Japan

Location

Boehringer Ingelheim Investigational Site

Iijima, Japan

Location

Boehringer Ingelheim Investigational Site

Ina, Japan

Location

Boehringer Ingelheim Investigational Site

Inazawa, Japan

Location

Boehringer Ingelheim Investigational Site

Isehara, Japan

Location

Boehringer Ingelheim Investigational Site

Isesaki, Japan

Location

Boehringer Ingelheim Investigational Site

Iwamizawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site

Kajiki, Japan

Location

Boehringer Ingelheim Investigational Site

Kanoya, Japan

Location

Boehringer Ingelheim Investigational Site

Kashiwazaki, Japan

Location

Boehringer Ingelheim Investigational Site

Kawagoe, Japan

Location

Boehringer Ingelheim Investigational Site

Kawasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Koga, Japan

Location

Boehringer Ingelheim Investigational Site

Koga, Japan

Location

Boehringer Ingelheim Investigational Site

Komae, Japan

Location

Boehringer Ingelheim Investigational Site

Koshigaya, Japan

Location

Boehringer Ingelheim Investigational Site

Kōriyama, Japan

Location

Boehringer Ingelheim Investigational Site

Kurashiki, Japan

Location

Boehringer Ingelheim Investigational Site

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site

Maebashi, Japan

Location

Boehringer Ingelheim Investigational Site

Marugame, Japan

Location

Boehringer Ingelheim Investigational Site

Matsudo, Japan

Location

Boehringer Ingelheim Investigational Site

Matsumoto, Japan

Location

Boehringer Ingelheim Investigational Site

Miki, Japan

Location

Boehringer Ingelheim Investigational Site

Mito, Japan

Location

Boehringer Ingelheim Investigational Site

Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site

Miyoshi, Japan

Location

Boehringer Ingelheim Investigational Site

Mooka, Japan

Location

Boehringer Ingelheim Investigational Site

Morioka, Japan

Location

Boehringer Ingelheim Investigational Site

Morohongō, Japan

Location

Boehringer Ingelheim Investigational Site

Nagahama, Japan

Location

Boehringer Ingelheim Investigational Site

Nagakute, Japan

Location

Boehringer Ingelheim Investigational Site

Nagasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site

Nanao, Japan

Location

Boehringer Ingelheim Investigational Site

Nangōku, Japan

Location

Boehringer Ingelheim Investigational Site

Narita, Japan

Location

Boehringer Ingelheim Investigational Site

Nishinomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Okayama, Japan

Location

Boehringer Ingelheim Investigational Site

Okinawa, Japan

Location

Boehringer Ingelheim Investigational Site

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site

Ōgaki, Japan

Location

Boehringer Ingelheim Investigational Site

Ōita, Japan

Location

Boehringer Ingelheim Investigational Site

Ōkawa, Japan

Location

Boehringer Ingelheim Investigational Site

Ōnojō, Japan

Location

Boehringer Ingelheim Investigational Site

Ōshū, Japan

Location

Boehringer Ingelheim Investigational Site

Sado, Japan

Location

Boehringer Ingelheim Investigational Site

Sagamihara, Japan

Location

Boehringer Ingelheim Investigational Site

Saitama, Japan

Location

Boehringer Ingelheim Investigational Site

Sanjō, Japan

Location

Boehringer Ingelheim Investigational Site

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site

Sekigahara, Japan

Location

Boehringer Ingelheim Investigational Site

Shimotsuke, Japan

Location

Boehringer Ingelheim Investigational Site

Shingū, Japan

Location

Boehringer Ingelheim Investigational Site

Shūnan, Japan

Location

Boehringer Ingelheim Investigational Site

Suita, Japan

Location

Boehringer Ingelheim Investigational Site

Takasago, Japan

Location

Boehringer Ingelheim Investigational Site

Takatsuki, Japan

Location

Boehringer Ingelheim Investigational Site

Togitsu, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Adachi-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Bunkyo-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Chiyoda-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Itabashi-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Meguro-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Ota-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Setagaya-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Shibuya-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Shinjuku-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Suginami-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Toride, Japan

Location

Boehringer Ingelheim Investigational Site

Toyoake, Japan

Location

Boehringer Ingelheim Investigational Site

Tsukuba, Japan

Location

Boehringer Ingelheim Investigational Site

Uki, Japan

Location

Boehringer Ingelheim Investigational Site

Wakayama, Japan

Location

Boehringer Ingelheim Investigational Site

Yamagata, Japan

Location

Boehringer Ingelheim Investigational Site

Yamaguchi, Japan

Location

Boehringer Ingelheim Investigational Site

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site

Yokosuka, Japan

Location

Boehringer Ingelheim Investigational Site

Yonago, Japan

Location

Boehringer Ingelheim Investigational Site

Yoshinogawa, Japan

Location

Boehringer Ingelheim Investigational Site

Yufu, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

February 1, 2004

Primary Completion

September 1, 2008

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

JP(98)