Conditions: Parkinson Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 475
Healthy volunteers: no

Brief summary:
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .

Detailed description:

Arms:
arm 1: subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement arm 2: subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement

Interventions: intervention 1: pramipexole immediate release tablet intervention 2: pramipexole extended release tablet
Intervention descriptions: intervention 1: 0.375mg-4.5mg(daily dose), three times a day intervention 2: 0.375mg-4.5mg, once a day

Protocol document: