Trial · NCT01361009
a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
NCT01361009, Completed, Boehringer Ingelheim; results first posted 2013-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients. Trials, record NCT01361009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01361009
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
- NCT number
- NCT01361009
- Status
- Completed
- Enrollment
- 2,017 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- pramipexole
- First posted
- 2011-05-26
- Last updated
- 2014-05-16
- Results first posted
- 2013-08-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of AE/SAE | 12 weeks | The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study. |
| Secondary | Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Baseline (Visit 1) and 12 weeks (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). |
| Secondary | The Dosage Related Information of Pramipexole at Baseline | baseline | At enrollment, the distribution of patients in 3 pramipexole dosage categories. |
| Secondary | The Dosage Related Information of Pramipexole at the End of Study | 12 weeks | At the end of study, the distribution of patients in 3 pramipexole dosage categories. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of AE/SAE | 12 weeks | 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. | Percentage of participants | NUMBER |
| SECONDARY | Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Baseline (Visit 1) and 12 weeks (Visit 3) | 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. | unit on a scale | MEAN |
| SECONDARY | The Dosage Related Information of Pramipexole at Baseline | baseline | There were 2017 patients in SAS set. | percentage of patients | NUMBER |
| SECONDARY | The Dosage Related Information of Pramipexole at the End of Study | 12 weeks | There were 2017 patients in SAS set | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of AE/SAE | Pramipexole Goup | 5.16 | Percentage of participants | ||
| Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Pramipexole Goup | Visit 1 | 3.53 | Standard Deviation 1.23 | unit on a scale |
| Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) | Pramipexole Goup | Visit 3 | 2.48 | Standard Deviation 0.69 | unit on a scale |
| The Dosage Related Information of Pramipexole at Baseline | Pramipexole Goup | dosage < 0.75mg/d | 84.93 | percentage of patients | |
| The Dosage Related Information of Pramipexole at Baseline | Pramipexole Goup | 1.5mg/d > dosage ≥ 0.75mg/d | 12.99 | percentage of patients | |
| The Dosage Related Information of Pramipexole at Baseline | Pramipexole Goup | dosage ≥ 1.5mg/d | 2.08 | percentage of patients | |
| The Dosage Related Information of Pramipexole at the End of Study | Pramipexole Goup | dosage < 0.75mg/d | 33.56 | percentage of patients | |
| The Dosage Related Information of Pramipexole at the End of Study | Pramipexole Goup | 1.5mg/d > dosage ≥ 0.75mg/d | 46.16 | percentage of patients | |
| The Dosage Related Information of Pramipexole at the End of Study | Pramipexole Goup | dosage ≥ 1.5mg/d | 20.28 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole Goup | 2,017 | |
| Overall Study | COMPLETED | Pramipexole Goup | 1,901 | |
| Overall Study | NOT COMPLETED | Pramipexole Goup | 116 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole Goup | ||
| Total, other adverse events | Pramipexole Goup | 0 | 2,017 |
| Total, serious adverse events | Pramipexole Goup | 0 | 2,017 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01361009
GET https://conductscience.org/api/trials/v1/NCT01361009/registered