Status:
COMPLETED
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
Detailed Description
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 m...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
- (1) Patients meeting all of the following inclusion criteria
- Patients of at least 20 years of age
- In- or outpatients of either sex.
- Patients in any stage on the modified Hoehn and Yahr severity scale
Exclusion
- Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
- Patients with subjective symptoms derived from orthostatic hypotension.
- Patients with hypotension (systolic blood pressure \<100 mmHg)
- Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
- Patients with a current or past history of epilepsy
- Pregnant, possibly pregnant, or lactating women
- Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
- Patients who judged incompetent to give consent
- Others judged by the investigator or co-investigator to be ineligible as subjects.
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00274131
Start Date
December 1 1998
End Date
February 1 2004
Last Update
May 21 2012
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