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a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

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ClinicalTrials.gov Identifier: NCT01361009
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : August 30, 2013
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.

Condition or disease Intervention/treatment
Parkinson Disease Drug: pramipexole

Detailed Description:
Purpose:

Study Type : Observational
Actual Enrollment : 2017 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
Study Start Date : May 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
pramipexole group
It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Drug: pramipexole
as prescibed by the investigator



Primary Outcome Measures :
  1. Incidence of AE/SAE [ Time Frame: 12 weeks ]
    The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.


Secondary Outcome Measures :
  1. Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) [ Time Frame: Baseline (Visit 1) and 12 weeks (Visit 3) ]
    Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).

  2. The Dosage Related Information of Pramipexole at Baseline [ Time Frame: baseline ]
    At enrollment, the distribution of patients in 3 pramipexole dosage categories.

  3. The Dosage Related Information of Pramipexole at the End of Study [ Time Frame: 12 weeks ]
    At the end of study, the distribution of patients in 3 pramipexole dosage categories.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
3000
Criteria

Inclusion criteria:

  1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria
  2. Age: from 30 to 75 years old
  3. Stage I-IV of revised Hoehn-Yahr standards
  4. With current use of pramipexole
  5. Informed consent signed by every subject

Exclusion criteria:

  1. Diagnosis of Parkinson¿s syndrome
  2. Current use of psychotolytic medications
  3. Allergic to pramipexole or any other ingredient of pramipexole
  4. Female patients in pregnancy and lactation
  5. Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study

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 ClinicalTrials.gov identifier (NCT number): NCT01361009


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01361009     History of Changes
Other Study ID Numbers: 248.682
First Posted: May 26, 2011    Key Record Dates
Results First Posted: August 30, 2013
Last Update Posted: May 16, 2014
Last Verified: June 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents