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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01361009
• Date of registration: 23/05/2011
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
• Scientific title: Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
• Date of first enrolment: May 2011
• Target sample size: 2017
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01361009
• Study type: Observational
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: pramipexole

Primary Outcome(s)

Incidence of AE/SAE [Time Frame: 12 weeks]

Secondary Outcome(s)

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)]

The Dosage Related Information of Pramipexole at the End of Study [Time Frame: 12 weeks]

The Dosage Related Information of Pramipexole at Baseline [Time Frame: baseline]

Secondary ID(s)

248.682

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/08/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01361009