Trial Outcomes & Findings for a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients (NCT NCT01361009)

Results Overview

The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.

Recruitment status

COMPLETED

Target enrollment

2017 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Pramipexole Goup An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Overall Study STARTED	2017
Overall Study COMPLETED	1901
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Reasons for withdrawal
Measure	Pramipexole Goup An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Overall Study Protocol Violation	116

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pramipexole Goup n=2017 Participants
Age, Continuous	62.09 years STANDARD_DEVIATION 9.67 • n=39 Participants
Gender Female	840 Number of participants n=39 Participants
Gender Male	1174 Number of participants n=39 Participants
Course of Parkinson's disease	3 years INTER_QUARTILE_RANGE 2.5 • n=39 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.

The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.

Outcome measures

Outcome measures
Measure	Pramipexole Goup n=2017 Participants An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Incidence of AE/SAE	5.16 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Visit 1) and 12 weeks (Visit 3)

Population: There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.

Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).

Outcome measures

Outcome measures
Measure	Pramipexole Goup n=1891 Participants An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) Visit 1	3.53 unit on a scale Standard Deviation 1.23
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) Visit 3	2.48 unit on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: baseline

Population: There were 2017 patients in SAS set.

At enrollment, the distribution of patients in 3 pramipexole dosage categories.

Outcome measures

Outcome measures
Measure	Pramipexole Goup n=2017 Participants An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
The Dosage Related Information of Pramipexole at Baseline dosage < 0.75mg/d	84.93 percentage of patients
The Dosage Related Information of Pramipexole at Baseline 1.5mg/d > dosage ≥ 0.75mg/d	12.99 percentage of patients
The Dosage Related Information of Pramipexole at Baseline dosage ≥ 1.5mg/d	2.08 percentage of patients

SECONDARY outcome

Timeframe: 12 weeks

Population: There were 2017 patients in SAS set

At the end of study, the distribution of patients in 3 pramipexole dosage categories.

Outcome measures

Outcome measures
Measure	Pramipexole Goup n=2017 Participants An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
The Dosage Related Information of Pramipexole at the End of Study dosage < 0.75mg/d	33.56 percentage of patients
The Dosage Related Information of Pramipexole at the End of Study 1.5mg/d > dosage ≥ 0.75mg/d	46.16 percentage of patients
The Dosage Related Information of Pramipexole at the End of Study dosage ≥ 1.5mg/d	20.28 percentage of patients

Adverse Events

Pramipexole Goup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER