Trial Outcomes & Findings for Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). (NCT NCT00601523)
NCT ID: NCT00601523
Last Updated: 2014-06-09
Results Overview
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Results posted on
2014-06-09
Participant Flow
Participant milestones
| Measure |
Patients From 248.524
Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
|
Patients From 248.636
Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
368
|
143
|
|
Overall Study
COMPLETED
|
291
|
117
|
|
Overall Study
NOT COMPLETED
|
77
|
26
|
Reasons for withdrawal
| Measure |
Patients From 248.524
Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
|
Patients From 248.636
Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
|
|---|---|---|
|
Overall Study
Adverse Event
|
42
|
14
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
18
|
9
|
|
Overall Study
Other
|
9
|
1
|
Baseline Characteristics
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Baseline characteristics by cohort
| Measure |
Patients From 248.524
n=368 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=143 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
62.7 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)Population: Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Outcome measures
| Measure |
Patients From 248.524
n=368 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=143 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Adverse Events
|
84.5 Percentage of participants
|
76.2 Percentage of participants
|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Adverse Drug Reactions
|
45.7 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Serious Adverse Events
|
14.4 Percentage of participants
|
14.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
Patients From 248.524
n=290 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=113 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
|
2.2 Units of scale
Standard Deviation 9.5
|
1.5 Units of scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
A response means an improvement of \>=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
Patients From 248.524
n=289 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=113 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
|
73 Patients
|
27 Patients
|
SECONDARY outcome
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood
Outcome measures
| Measure |
Patients From 248.524
n=287 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=111 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
UPDRS I Total Score: Change From OL Baseline
|
0.3 Units of scale
Standard Deviation 1.0
|
0.1 Units of scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.
Outcome measures
| Measure |
Patients From 248.524
n=290 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=113 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
UPDRS II Total Score: Change From OL Baseline
|
1.0 Units of scale
Standard Deviation 3.2
|
0.6 Units of scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms
Outcome measures
| Measure |
Patients From 248.524
n=290 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=113 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
UPDRS III Total Score: Change From OL Baseline
|
1.1 Units of scale
Standard Deviation 7.2
|
0.9 Units of scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)Population: Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders
Outcome measures
| Measure |
Patients From 248.524
n=336 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=133 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Response in Clinical Global Impression of Improvement (CGI-I)
|
284 Patients
|
108 Patients
|
SECONDARY outcome
Timeframe: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)Population: Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders
Outcome measures
| Measure |
Patients From 248.524
n=336 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=133 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Response in Patient Global Impression of Improvement (PGI-I)
|
265 Patients
|
111 Patients
|
SECONDARY outcome
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.
Outcome measures
| Measure |
Patients From 248.524
n=303 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=110 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
|
2.0 Units of scale
Standard Deviation 12.5
|
2.2 Units of scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)Population: Patients from FAS
Number of patients requiring Levodopa supplementation during the study
Outcome measures
| Measure |
Patients From 248.524
n=367 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=138 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Number of Patients Introducing L-Dopa Medication in OL Trial
No
|
320 Patients
|
117 Patients
|
|
Number of Patients Introducing L-Dopa Medication in OL Trial
Yes
|
47 Patients
|
21 Patients
|
SECONDARY outcome
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)Population: Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)
Change from open-label baseline in Levodopa dose
Outcome measures
| Measure |
Patients From 248.524
n=32 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=64 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
L-Dopa Dose: Change From OL Baseline
Decrease
|
4 Patients
|
0 Patients
|
|
L-Dopa Dose: Change From OL Baseline
Increase
|
9 Patients
|
23 Patients
|
|
L-Dopa Dose: Change From OL Baseline
No change
|
19 Patients
|
41 Patients
|
SECONDARY outcome
Timeframe: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)Population: Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)
Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment
Outcome measures
| Measure |
Patients From 248.524
n=339 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=126 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
Decrease
|
101 Patients
|
9 Patients
|
|
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
Increase
|
82 Patients
|
44 Patients
|
|
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
No change
|
156 Patients
|
73 Patients
|
SECONDARY outcome
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)
Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing
Outcome measures
| Measure |
Patients From 248.524
n=367 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=138 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Patient Preference Regarding Treatment Dosing
Missing
|
76 participants
|
55 participants
|
|
Patient Preference Regarding Treatment Dosing
Prefer Once Daily dosing
|
275 participants
|
78 participants
|
|
Patient Preference Regarding Treatment Dosing
Prefer 3 Times Daily dosing
|
9 participants
|
1 participants
|
|
Patient Preference Regarding Treatment Dosing
No Preference
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)
Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing
Outcome measures
| Measure |
Patients From 248.524
n=367 Participants
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=138 Participants
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Patient Rating of Convenience of Treatment Dosing
Once Daily much more convenient
|
196 participants
|
59 participants
|
|
Patient Rating of Convenience of Treatment Dosing
Once Daily more convenient
|
79 participants
|
19 participants
|
|
Patient Rating of Convenience of Treatment Dosing
3 Times Daily much more convenient
|
2 participants
|
0 participants
|
|
Patient Rating of Convenience of Treatment Dosing
3 Times Daily more convenient
|
6 participants
|
1 participants
|
|
Patient Rating of Convenience of Treatment Dosing
No difference in preference
|
7 participants
|
4 participants
|
|
Patient Rating of Convenience of Treatment Dosing
Missing
|
77 participants
|
55 participants
|
Adverse Events
Patients From 248.524
Serious events: 53 serious events
Other events: 214 other events
Deaths: 0 deaths
Patients From 248.636
Serious events: 21 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients From 248.524
n=368 participants at risk
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=143 participants at risk
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Angina pectoris
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Cardiac tamponade
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Coronary artery disease
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Coronary artery stenosis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Left ventricular failure
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
4/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Cardiac disorders
Myocardial rupture
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Enteritis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
General disorders
Drowning
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
General disorders
Malaise
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Hepatobiliary disorders
Hepatitis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Borrelia infection
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Bronchitis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Endocarditis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Herpes zoster
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Infection
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Pneumonia
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Prostatic abscess
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Respiratory tract infection
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Septic shock
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Fall
|
0.82%
3/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
3.5%
5/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
2.1%
3/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Investigations
Arthroscopy
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
1.4%
2/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Aphasia
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Cervical root pain
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Epilepsy
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
On and off phenomenon
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Parkinson's disease
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
1.4%
2/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Sciatica
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Confusional state
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Hallucination
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Psychotic disorder
|
0.54%
2/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Sleep attacks
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Renal and urinary disorders
Hydronephrosis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Renal and urinary disorders
Hydroureter
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Renal and urinary disorders
Renal failure acute
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Reproductive system and breast disorders
Cystocele
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Vascular disorders
Varicose vein
|
0.27%
1/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.00%
0/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
Other adverse events
| Measure |
Patients From 248.524
n=368 participants at risk
Patients who had previously completed 248.524 (NCT00479401)
|
Patients From 248.636
n=143 participants at risk
Patients who had previously completed 248.636 (NCT00558025)
|
|---|---|---|
|
Eye disorders
Cataract
|
6.8%
25/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
4.9%
7/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Constipation
|
4.1%
15/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
6.3%
9/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Gastrointestinal disorders
Nausea
|
10.1%
37/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
7.0%
10/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
General disorders
Oedema peripheral
|
12.2%
45/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
10.5%
15/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
29/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
5.6%
8/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
20/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
0.70%
1/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
40/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
9.1%
13/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Dizziness
|
8.7%
32/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
2.1%
3/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Parkinson's disease
|
1.9%
7/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
7.0%
10/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Nervous system disorders
Somnolence
|
18.2%
67/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
7.0%
10/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Hallucination
|
2.2%
8/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
5.6%
8/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
|
Psychiatric disorders
Insomnia
|
5.2%
19/368 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
4.2%
6/143 • Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636
|
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