Special Survey on PD Patients With Renal Dysfunction

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 98 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Parkinson Disease
How many people: 107 participants
Where: 98 sitesJapan
Study dates: Feb 2004to Sep 2008
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with idiopathic PD with renal dysfunction from Primary Care setting.

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

98 sites in 1 country.

City, postcode or hospital

98 sites in 1 country

Japan98 sites

Boehringer Ingelheim Investigational Site
Asahikawa
Boehringer Ingelheim Investigational Site
Azumino
Boehringer Ingelheim Investigational Site
Chūō
Boehringer Ingelheim Investigational Site
Fuji
Boehringer Ingelheim Investigational Site
Fujinomiya
Boehringer Ingelheim Investigational Site
Fujisaki
Boehringer Ingelheim Investigational Site
Fukaya
Boehringer Ingelheim Investigational Site
Fukui
Boehringer Ingelheim Investigational Site
Fukuoka
Boehringer Ingelheim Investigational Site
Gifu
Boehringer Ingelheim Investigational Site
Hachiōji
Boehringer Ingelheim Investigational Site
Hamamatsu
Boehringer Ingelheim Investigational Site
Himeji
Boehringer Ingelheim Investigational Site
Hiroshima
Boehringer Ingelheim Investigational Site
Ichinoseki
Boehringer Ingelheim Investigational Site
Iga
Boehringer Ingelheim Investigational Site
Iida
Boehringer Ingelheim Investigational Site
Iijima
Boehringer Ingelheim Investigational Site
Ina
Boehringer Ingelheim Investigational Site
Inazawa
Boehringer Ingelheim Investigational Site
Isehara
Boehringer Ingelheim Investigational Site
Isesaki
Boehringer Ingelheim Investigational Site
Iwamizawa
Boehringer Ingelheim Investigational Site
Kagoshima
Boehringer Ingelheim Investigational Site
Kajiki
Boehringer Ingelheim Investigational Site
Kanoya
Boehringer Ingelheim Investigational Site
Kashiwazaki
Boehringer Ingelheim Investigational Site
Kawagoe
Boehringer Ingelheim Investigational Site
Kawasaki
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Komae
Boehringer Ingelheim Investigational Site
Kōriyama
Boehringer Ingelheim Investigational Site
Koshigaya
Boehringer Ingelheim Investigational Site
Kurashiki
Boehringer Ingelheim Investigational Site
Kyoto
Boehringer Ingelheim Investigational Site
Maebashi
Boehringer Ingelheim Investigational Site
Marugame
Boehringer Ingelheim Investigational Site
Matsudo
Boehringer Ingelheim Investigational Site
Matsumoto
Boehringer Ingelheim Investigational Site
Miki
Boehringer Ingelheim Investigational Site
Mito
Boehringer Ingelheim Investigational Site
Miyazaki
Boehringer Ingelheim Investigational Site
Miyoshi
Boehringer Ingelheim Investigational Site
Mooka
Boehringer Ingelheim Investigational Site
Morioka
Boehringer Ingelheim Investigational Site
Morohongō
Boehringer Ingelheim Investigational Site
Nagahama
Boehringer Ingelheim Investigational Site
Nagakute
Boehringer Ingelheim Investigational Site
Nagasaki
Boehringer Ingelheim Investigational Site
Nagoya
Boehringer Ingelheim Investigational Site
Nanao
Boehringer Ingelheim Investigational Site
Nangōku
Boehringer Ingelheim Investigational Site
Narita
Boehringer Ingelheim Investigational Site
Nishinomiya
Boehringer Ingelheim Investigational Site
Ōgaki
Boehringer Ingelheim Investigational Site
Ōita
Boehringer Ingelheim Investigational Site
Ōkawa
Boehringer Ingelheim Investigational Site
Okayama
Boehringer Ingelheim Investigational Site
Okinawa
Boehringer Ingelheim Investigational Site
Ōnojō
Boehringer Ingelheim Investigational Site
Osaka
Boehringer Ingelheim Investigational Site
Ōshū
Boehringer Ingelheim Investigational Site
Sado
Boehringer Ingelheim Investigational Site
Sagamihara
Boehringer Ingelheim Investigational Site
Saitama
Boehringer Ingelheim Investigational Site
Sanjō
Boehringer Ingelheim Investigational Site
Sapporo
Boehringer Ingelheim Investigational Site
Sekigahara
Boehringer Ingelheim Investigational Site
Shimotsuke
Boehringer Ingelheim Investigational Site
Shingū
Boehringer Ingelheim Investigational Site
Shūnan
Boehringer Ingelheim Investigational Site
Suita
Boehringer Ingelheim Investigational Site
Takasago
Boehringer Ingelheim Investigational Site
Takatsuki
Boehringer Ingelheim Investigational Site
Togitsu
Boehringer Ingelheim Investigational Site
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku
Boehringer Ingelheim Investigational Site
Tokyo Shibuya-ku
Boehringer Ingelheim Investigational Site
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site
Tokyo Suginami-ku
Boehringer Ingelheim Investigational Site
Toride
Boehringer Ingelheim Investigational Site
Toyoake
Boehringer Ingelheim Investigational Site
Tsukuba
Boehringer Ingelheim Investigational Site
Uki
Boehringer Ingelheim Investigational Site
Wakayama
Boehringer Ingelheim Investigational Site
Yamagata
Boehringer Ingelheim Investigational Site
Yamaguchi
Boehringer Ingelheim Investigational Site
Yokohama
Boehringer Ingelheim Investigational Site
Yokosuka
Boehringer Ingelheim Investigational Site
Yonago
Boehringer Ingelheim Investigational Site
Yoshinogawa
Boehringer Ingelheim Investigational Site
Yufu

Other trials in Japan

About this study

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

Conditions: Parkinson Disease
Medical subject headings: Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events
Measured: up to 12 weeks
Incidence of adverse drug reactions (ADRs
Measured: up to 12 weeks
Incidence of serious adverse events (SAEs)
Measured: up to 12 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Sep 2008

First posted13 Feb 2008 (estimated)
Study startFeb 2004
Primary completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613756
Sponsor's protocol ID: 248.548
Status last verified: Nov 2013
First submitted: 31 Jan 2008
Last updated: 13 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction
ClinicalTrials.gov ID: NCT00613756
Acronym / sponsor ID: 248.548
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Sep 2008 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with idiopathic PD with renal dysfunction from Primary Care setting.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.

Related trials for Parkinson Disease

Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

98 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 98 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.