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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01361009
First received: May 23, 2011
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: An Open-label, Observational Study on the Safety Profile of Parkinson's Disease Patients in China Who Use Pramipexole Over 12 Weeks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Secondary Outcome Measures:
  • Patients Global impression (PGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Total number of adverse events (AE) including their frequency of occurrence in the whole observational period [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • vital signs ( blood pressure,pulse rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • laboratory test( ECG, liver function test, renal function test, blood cell counting) [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • Patient characteristics/demographics: for example, the disease duration, Modified Hoehn & Yahr class, male or female, age [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • Total number of serious adverse events (SAE) including their frequency of occurrence in the whole observational period [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Number of drug withdrawals per total number of participants in the observational period as well as the corresponding reasons [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • The initial drugs administration and the change in the observational period,for example,the name, dosage, frequency,combination pattern [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • New additive drugs(except for the initial drugs),for example, the name, dosage, frequency, combination pattern [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 3000
Study Start Date: May 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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. Hoehn & Yahr stage I-IV
  4. Patients who are using pramipexole monotherapy or any kinds of combination therapy could be enrolled in this surveillance.
  5. Patients who agree to participate the study and subscribe the Informed consent

Exclusion criteria:

  1. With the diagnosis of atypical parkinsonian syndromes
  2. Under the treatment of psychotropic drugs at present
  3. Allergic to pramipexole or any other ingredient of pramipexole
  4. Female patients in pregnancy and lactation
  5. Patients who were participating in other drug studies or who received other investigational drugs within 30 days prior to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361009

  Show 103 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01361009     History of Changes
Other Study ID Numbers: 248.682
Study First Received: May 23, 2011
Last Updated: June 27, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013