At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 475 enrolled
Drug / intervention
pramipexole immediate release tablet +1 moredrug
Likely dose
pramipexole immediate release tablet 0.375mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
In Brief
A Phase 3 clinical trial evaluating pramipexole immediate release tablet and pramipexole extended release tablet for Parkinson Disease. Completed, enrolled 475 participants across 20 sites.
Detailed 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 .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedAug 31, 2010
Enrollment StartAug 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.8 years ago
Interventions
pramipexole immediate release tabletdrug
0.375mg-4.5mg(daily dose), three times a day
pramipexole extended release tabletdrug
0.375mg-4.5mg, once a day