The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinson's disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators (phase III comparative trial).~For efficacy evaluation, two primary endpoints were chosen:~Totalled score according to Part III of UPDRS (motor examination)~Totalled score according to Part II of UPDRS (activities of daily living)~The safety profile of the study drug was evaluated by physical examination, blood pressure, Electrocardiogram, Laboratory tests, AEs and SAEs.~Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups, i.e., Pramipexole tablets or Bromocriptine tablets. Patients were administered the study drug according to the dosing schedule.~The treatment period lasted maximal 12 weeks (ascending dose interval: up to 8 weeks, maintenance dose interval: 4 weeks or longer). In addition, a descending dose interval was 1-4 weeks.~Each patient received 7 visits except the patients drops or withdrawals:~visit 1: screening visit 2: randomization and baseline visit 3-6: ascending dose interval visit 7: Maintenance dose interval~Study Hypothesis:~Primary variables are both total of UPDRS (Unified Parkinson's Disease Rating Scale) part III items and of UPDRS part II items in change from baseline. The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margin(=delta; the clinically largest difference judged as clinically acceptable) with 90% power, one sided for the above two primary variables at the error probability of 2.5% each. The equivalency margin for the primary variables (total of UPDRS Part III, and of UPDRS Part II) can be determined as 2.0 and 1.0 respectively referring to the results of oversea pivotal study of Pramipexole (BI Trial No. 248.326; U96-0232) and judged by the study investigator.~Comparison(s):~The primary endpoint of the study was the change of totalled score according to Part III of UPDRS (motor examination) and totalled score according to Part II of UPDRS (activities of daily living) after 12 weeks treatment of the study drug.
The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial)