Trial Outcomes & Findings for Efficacy of Isradipine in Early Parkinson Disease (NCT NCT02168842)
NCT ID: NCT02168842
Last Updated: 2020-01-14
Results Overview
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
336 participants
Primary outcome timeframe
Baseline to 36 months of treatment
Results posted on
2020-01-14
Participant Flow
Patients were recruited from 57 Parkinson Study Group sites in North America from November 2014 through November 2015.
413 patients were assessed for eligibility. 12 patients declined to participate and 65 patients were excluded (9 exclusionary medications, 2 other medical psychiatric or surgical, 5 disease too advanced, 6 diagnosis uncertain, 23 didn't meet other inclusion criteria, 20 other). 336 patients were enrolled and underwent randomization
Participant milestones
| Measure |
Isradipine
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
|
Placebo (for Isradipine)
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
166
|
|
Overall Study
COMPLETED
|
162
|
158
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Isradipine
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
|
Placebo (for Isradipine)
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
Baseline Characteristics
One participant had missing baseline UPDRS
Baseline characteristics by cohort
| Measure |
Isradipine
n=170 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.11 years
STANDARD_DEVIATION 8.73 • n=170 Participants
|
61.61 years
STANDARD_DEVIATION 9.34 • n=166 Participants
|
61.86 years
STANDARD_DEVIATION 9.03 • n=336 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=170 Participants
|
58 Participants
n=166 Participants
|
106 Participants
n=336 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=170 Participants
|
108 Participants
n=166 Participants
|
230 Participants
n=336 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=170 Participants
|
6 Participants
n=166 Participants
|
10 Participants
n=336 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=170 Participants
|
160 Participants
n=166 Participants
|
326 Participants
n=336 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=170 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=336 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=170 Participants
|
1 Participants
n=166 Participants
|
2 Participants
n=336 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=170 Participants
|
5 Participants
n=166 Participants
|
11 Participants
n=336 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=170 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=336 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=170 Participants
|
7 Participants
n=166 Participants
|
10 Participants
n=336 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=170 Participants
|
149 Participants
n=166 Participants
|
308 Participants
n=336 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=170 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=336 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=170 Participants
|
3 Participants
n=166 Participants
|
4 Participants
n=336 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=170 Participants
|
149 participants
n=166 Participants
|
303 participants
n=336 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=170 Participants
|
17 participants
n=166 Participants
|
33 participants
n=336 Participants
|
|
Disease Duration
|
9.89 months
STANDARD_DEVIATION 8.13 • n=170 Participants
|
10.56 months
STANDARD_DEVIATION 9.35 • n=166 Participants
|
10.22 months
STANDARD_DEVIATION 8.75 • n=336 Participants
|
|
Family History of PD
|
30 Participants
n=170 Participants
|
35 Participants
n=166 Participants
|
65 Participants
n=336 Participants
|
|
Handedness
Right
|
147 Participants
n=170 Participants
|
142 Participants
n=166 Participants
|
289 Participants
n=336 Participants
|
|
Handedness
Left
|
20 Participants
n=170 Participants
|
19 Participants
n=166 Participants
|
39 Participants
n=336 Participants
|
|
Handedness
Mixed
|
3 Participants
n=170 Participants
|
5 Participants
n=166 Participants
|
8 Participants
n=336 Participants
|
|
On Symptomatic Therapy (Amantadine)
|
15 Participants
n=170 Participants
|
11 Participants
n=166 Participants
|
26 Participants
n=336 Participants
|
|
On Symptomatic Therapy (Anticholinergics)
|
3 Participants
n=170 Participants
|
2 Participants
n=166 Participants
|
5 Participants
n=336 Participants
|
|
UPDRS Total Score
|
23.66 units on a scale
STANDARD_DEVIATION 8.64 • n=170 Participants • One participant had missing baseline UPDRS
|
22.58 units on a scale
STANDARD_DEVIATION 8.53 • n=165 Participants • One participant had missing baseline UPDRS
|
23.13 units on a scale
STANDARD_DEVIATION 8.59 • n=335 Participants • One participant had missing baseline UPDRS
|
|
Mental Scale
|
0.61 units on a scale
STANDARD_DEVIATION 0.87 • n=170 Participants • One participant had missing baseline UPDRS
|
0.81 units on a scale
STANDARD_DEVIATION 1.21 • n=165 Participants • One participant had missing baseline UPDRS
|
0.71 units on a scale
STANDARD_DEVIATION 1.05 • n=335 Participants • One participant had missing baseline UPDRS
|
|
ADL Scale
|
4.96 units on a scale
STANDARD_DEVIATION 2.88 • n=170 Participants • One participant had missing baseline UPDRS
|
5.45 units on a scale
STANDARD_DEVIATION 3.26 • n=165 Participants • One participant had missing baseline UPDRS
|
5.2 units on a scale
STANDARD_DEVIATION 3.08 • n=335 Participants • One participant had missing baseline UPDRS
|
|
Motor Scale
|
18.08 units on a scale
STANDARD_DEVIATION 7.3 • n=170 Participants • One participant had missing baseline UPDRS
|
16.32 units on a scale
STANDARD_DEVIATION 6.53 • n=165 Participants • One participant had missing baseline UPDRS
|
17.21 units on a scale
STANDARD_DEVIATION 6.97 • n=335 Participants • One participant had missing baseline UPDRS
|
|
UPSDRS PIGD Score
|
0.17 units on a scale
STANDARD_DEVIATION 0.19 • n=170 Participants • One participant had missing baseline UPDRS PIGD Score
|
0.17 units on a scale
STANDARD_DEVIATION 0.17 • n=165 Participants • One participant had missing baseline UPDRS PIGD Score
|
0.17 units on a scale
STANDARD_DEVIATION 0.18 • n=335 Participants • One participant had missing baseline UPDRS PIGD Score
|
|
UPDRS Tremor Score
|
0.51 units on a scale
STANDARD_DEVIATION 0.32 • n=170 Participants • One participant had missing baseline UPDRS Tremor Score
|
0.50 units on a scale
STANDARD_DEVIATION 0.29 • n=165 Participants • One participant had missing baseline UPDRS Tremor Score
|
0.51 units on a scale
STANDARD_DEVIATION 0.3 • n=335 Participants • One participant had missing baseline UPDRS Tremor Score
|
|
H/Y Stage
|
1.72 units on a scale
STANDARD_DEVIATION 0.46 • n=170 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 0.5 • n=166 Participants
|
1.66 units on a scale
STANDARD_DEVIATION 0.48 • n=336 Participants
|
|
SE/ADL
|
94.44 units on a scale
STANDARD_DEVIATION 5.23 • n=170 Participants
|
94.04 units on a scale
STANDARD_DEVIATION 6.8 • n=166 Participants
|
94.24 units on a scale
STANDARD_DEVIATION 6.05 • n=336 Participants
|
|
Modified Rankin Score
|
1.09 units on a scale
STANDARD_DEVIATION 0.31 • n=170 Participants
|
1.09 units on a scale
STANDARD_DEVIATION 0.33 • n=166 Participants
|
1.09 units on a scale
STANDARD_DEVIATION 0.32 • n=336 Participants
|
|
MoCA Score
|
28.14 units on a scale
STANDARD_DEVIATION 1.41 • n=170 Participants
|
28.04 units on a scale
STANDARD_DEVIATION 1.29 • n=166 Participants
|
28.09 units on a scale
STANDARD_DEVIATION 1.35 • n=336 Participants
|
|
BDI Total Score
|
4.09 units on a scale
STANDARD_DEVIATION 3.71 • n=170 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 4.29 • n=166 Participants
|
4.44 units on a scale
STANDARD_DEVIATION 4.02 • n=336 Participants
|
|
PDQ39 Total Score
|
7.13 units on a scale
STANDARD_DEVIATION 6.15 • n=170 Participants
|
9.08 units on a scale
STANDARD_DEVIATION 8.52 • n=166 Participants
|
8.10 units on a scale
STANDARD_DEVIATION 7.47 • n=336 Participants
|
|
Systolic BP, Seated
|
128.12 mmHg
STANDARD_DEVIATION 17.17 • n=170 Participants
|
127.69 mmHg
STANDARD_DEVIATION 14.6 • n=166 Participants
|
127.91 mmHg
STANDARD_DEVIATION 15.93 • n=336 Participants
|
|
Diastolic BP, Seated
|
76.55 mmHg
STANDARD_DEVIATION 9.72 • n=170 Participants
|
77.83 mmHg
STANDARD_DEVIATION 8.52 • n=166 Participants
|
77.18 mmHg
STANDARD_DEVIATION 9.16 • n=336 Participants
|
PRIMARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score
|
2.99 score on a scale
Interval 0.95 to 5.03
|
3.26 score on a scale
Interval 1.25 to 5.26
|
PRIMARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Adjusted UPDRS Score
|
13.49 score on a scale
Interval 11.32 to 15.66
|
13.85 score on a scale
Interval 11.72 to 15.98
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED measurement. So LED had 1 more observation than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in LED
|
389 mg
Interval 337.0 to 441.0
|
375 mg
Interval 325.0 to 426.0
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED Cumulative measurement. So LED Cumulative had 1 more observation than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in LED Cumulative
|
676 mg
Interval 588.0 to 765.0
|
697 mg
Interval 611.0 to 784.0
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. 46 patients had missing measures at the visit of 36 months.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=134 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=140 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS Part IV
|
1.18 score on a scale
Interval 0.9 to 1.46
|
1.07 score on a scale
Interval 0.8 to 1.33
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in MDS-UPDRS nmEDL
|
1.93 score on a scale
Interval 1.28 to 2.59
|
1.76 score on a scale
Interval 1.13 to 2.4
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in MDS-UPDRS mEDL
|
2.32 score on a scale
Interval 1.52 to 3.12
|
2.57 score on a scale
Interval 1.78 to 3.35
|
SECONDARY outcome
Timeframe: Baseline to 12 months of treatmentPopulation: Intention-to-treat (ITT) population. There were 169 patients in Isradipine group and 165 in placebo group who reached 1-year visit.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=169 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=165 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS Score to 1 Year
|
4.65 score on a scale
Interval 3.59 to 5.7
|
5.3 score on a scale
Interval 4.25 to 6.35
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS Part II
|
2.3 score on a scale
Interval 1.63 to 3.97
|
2.5 score on a scale
Interval 1.83 to 3.16
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. 58 patients had missing measures at the visit of 36 months.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=129 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=133 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS Part III OFF
|
4.60 score on a scale
Interval 3.05 to 6.14
|
4.50 score on a scale
Interval 3.02 to 5.98
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline SE/ADL measurement. So SE/ADL had 1 more observation than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in SE/ADL
|
-4.14 units on a scale
Interval -5.3 to -2.98
|
-4.41 units on a scale
Interval -5.54 to -3.27
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline measurement for primary efficacy while had finished baseline Modified Rankin Score. So Modified Rankin Score had 1 more observation than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Modified Rankin Score
|
0.18 units on a scale
Interval 0.07 to 0.28
|
0.29 units on a scale
Interval 0.18 to 0.39
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline MoCA Score. So MoCA Score had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in MoCA Score
|
-0.04 units on a scale
Interval -0.36 to 0.28
|
-0.07 units on a scale
Interval -0.39 to 0.25
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. 7 patients had missing PDQ39 scores at the visit of 36 months.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=158 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=155 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in PDQ39 Total Score
|
2.80 units on a scale
Interval 1.42 to 4.18
|
3.42 units on a scale
Interval 2.07 to 4.77
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Ambulatory Capacity
|
0.59 score on a scale
Interval 0.34 to 0.85
|
0.50 score on a scale
Interval 0.25 to 0.75
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant in Placebo group had missing baseline UPDRS sections while had finished baseline BDI Score. And one participant in Isradipine group had missing BDI score at the visit of 36 months.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=161 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in BDI Total Score
|
0.77 units on a scale
Interval 0.05 to 1.49
|
1.34 units on a scale
Interval 0.63 to 2.04
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Include all 336 patients that were randomized, no matter whether or not completed the study.
Number of participants with need for Antiparkinsonian Therapy.
Outcome measures
| Measure |
Isradipine
n=170 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Risk of Need for Antiparkinsonian Therapy
|
145 participants
Interval 134.0 to 153.0
|
147 participants
Interval 138.0 to 154.0
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Include all 336 patients that were randomized, no matter whether or not completed the study.
Number of participants with need for Dyskinesia Therapy.
Outcome measures
| Measure |
Isradipine
n=170 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Risk of Need for Dyskinesia
|
24 participants
Interval 17.0 to 34.0
|
19 participants
Interval 12.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Include all 336 patients that were randomized, no matter whether or not completed the study.
Number of participants with need for Fluctuations Therapy.
Outcome measures
| Measure |
Isradipine
n=170 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Risk of Need for Fluctuations
|
57 participants
Interval 46.0 to 70.0
|
64 participants
Interval 51.0 to 76.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS PIGD Score
|
0.12 units on a scale
Interval 0.07 to 0.17
|
0.10 units on a scale
Interval 0.05 to 0.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=158 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in UPDRS Tremor Score
|
0.00 units on a scale
Interval -0.05 to 0.05
|
0.01 units on a scale
Interval -0.03 to 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline H/Y Stage. So H/Y Stage had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in H/Y Stage
|
0.15 units on a scale
Interval 0.09 to 0.22
|
0.21 units on a scale
Interval 0.15 to 0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa. So Levodopa had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Levodopa
|
307 mg
Interval 257.0 to 356.0
|
307 mg
Interval 259.0 to 355.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa Cumulative. So Levodopa Cumulative had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Levodopa Cumulative
|
471 mg
Interval 388.0 to 555.0
|
508 mg
Interval 426.0 to 590.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Systolic BP, Seated. So Systolic BP had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Systolic BP, Seated
|
-6.11 mmHg
Interval -8.28 to -3.95
|
1.03 mmHg
Interval -1.1 to 3.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 36 months of treatmentPopulation: Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Diastolic BP, Seated. So Diastolic BP had 1 observation more than primary outcomes.
Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions.
Outcome measures
| Measure |
Isradipine
n=162 Participants
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=159 Participants
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Adjusted Mean Change in Diastolic BP, Seated
|
-4.64 mmHg
Interval -5.93 to -3.36
|
-0.71 mmHg
Interval -1.96 to 0.55
|
Adverse Events
Isradipine
Serious events: 26 serious events
Other events: 163 other events
Deaths: 2 deaths
Placebo (for Isradipine)
Serious events: 27 serious events
Other events: 154 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Isradipine
n=170 participants at risk
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 participants at risk
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.8%
3/170 • Number of events 4 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
SEPSIS
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
STRESS FRACTURE
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Nervous system disorders
SYNCOPE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
APHASIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
APPENDICEAL MUCOCOELE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
BASAL GANGLIA HAEMORRHAGE
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Cardiac disorders
BRADYCARDIA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Infections and infestations
BRONCHIOLITIS
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
General disorders
CHEST DISCOMFORT
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOROID MELANOMA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
HYPERTENSIVE ENCEPHALOPATHY
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEOPLASM
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Congenital, familial and genetic disorders
SPINA BIFIDA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THROAT CANCER
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/170 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
Other adverse events
| Measure |
Isradipine
n=170 participants at risk
Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.
Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily
|
Placebo (for Isradipine)
n=166 participants at risk
Oral capsule taken twice daily for 36 months.
Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients
|
|---|---|---|
|
Nervous system disorders
DIZZINESS
|
24.7%
42/170 • Number of events 55 • Baseline to 36 months of treatment
|
15.7%
26/166 • Number of events 30 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
NAUSEA
|
15.3%
26/170 • Number of events 29 • Baseline to 36 months of treatment
|
19.3%
32/166 • Number of events 38 • Baseline to 36 months of treatment
|
|
Nervous system disorders
HEADACHE
|
16.5%
28/170 • Number of events 40 • Baseline to 36 months of treatment
|
10.2%
17/166 • Number of events 19 • Baseline to 36 months of treatment
|
|
General disorders
OEDEMA
|
18.2%
31/170 • Number of events 41 • Baseline to 36 months of treatment
|
5.4%
9/166 • Number of events 11 • Baseline to 36 months of treatment
|
|
Infections and infestations
NASOPHARYNGITIS
|
13.5%
23/170 • Number of events 26 • Baseline to 36 months of treatment
|
13.3%
22/166 • Number of events 23 • Baseline to 36 months of treatment
|
|
General disorders
FATIGUE
|
13.5%
23/170 • Number of events 28 • Baseline to 36 months of treatment
|
12.0%
20/166 • Number of events 21 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
13.5%
23/170 • Number of events 24 • Baseline to 36 months of treatment
|
12.7%
21/166 • Number of events 22 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
17/170 • Number of events 19 • Baseline to 36 months of treatment
|
12.0%
20/166 • Number of events 26 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
INSOMNIA
|
11.2%
19/170 • Number of events 22 • Baseline to 36 months of treatment
|
11.4%
19/166 • Number of events 20 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
ANXIETY
|
11.8%
20/170 • Number of events 22 • Baseline to 36 months of treatment
|
7.8%
13/166 • Number of events 16 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
DEPRESSION
|
11.8%
20/170 • Number of events 22 • Baseline to 36 months of treatment
|
7.8%
13/166 • Number of events 14 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.0%
17/170 • Number of events 20 • Baseline to 36 months of treatment
|
9.0%
15/166 • Number of events 16 • Baseline to 36 months of treatment
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.1%
12/170 • Number of events 13 • Baseline to 36 months of treatment
|
6.6%
11/166 • Number of events 20 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
FALL
|
4.1%
7/170 • Number of events 10 • Baseline to 36 months of treatment
|
9.0%
15/166 • Number of events 20 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.1%
12/170 • Number of events 14 • Baseline to 36 months of treatment
|
9.0%
15/166 • Number of events 15 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.5%
11/170 • Number of events 12 • Baseline to 36 months of treatment
|
7.8%
13/166 • Number of events 15 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.5%
11/170 • Number of events 14 • Baseline to 36 months of treatment
|
5.4%
9/166 • Number of events 11 • Baseline to 36 months of treatment
|
|
Infections and infestations
SINUSITIS
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
7.8%
13/166 • Number of events 17 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
9/170 • Number of events 11 • Baseline to 36 months of treatment
|
5.4%
9/166 • Number of events 11 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
7.1%
12/170 • Number of events 13 • Baseline to 36 months of treatment
|
4.2%
7/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Nervous system disorders
SOMNOLENCE
|
5.9%
10/170 • Number of events 11 • Baseline to 36 months of treatment
|
4.8%
8/166 • Number of events 9 • Baseline to 36 months of treatment
|
|
Nervous system disorders
HYPOAESTHESIA
|
4.7%
8/170 • Number of events 11 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
4.7%
8/170 • Number of events 9 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 9 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
SLEEP DISORDER
|
5.3%
9/170 • Number of events 9 • Baseline to 36 months of treatment
|
4.8%
8/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Infections and infestations
BRONCHITIS
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
6.6%
11/166 • Number of events 12 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.9%
5/170 • Number of events 6 • Baseline to 36 months of treatment
|
5.4%
9/166 • Number of events 11 • Baseline to 36 months of treatment
|
|
Vascular disorders
HYPERTENSION
|
4.7%
8/170 • Number of events 8 • Baseline to 36 months of treatment
|
4.8%
8/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.1%
7/170 • Number of events 11 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
3.5%
6/170 • Number of events 7 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Eye disorders
CATARACT
|
2.4%
4/170 • Number of events 6 • Baseline to 36 months of treatment
|
4.2%
7/166 • Number of events 9 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
DYSPHAGIA
|
4.1%
7/170 • Number of events 9 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
POLLAKIURIA
|
4.1%
7/170 • Number of events 7 • Baseline to 36 months of treatment
|
4.2%
7/166 • Number of events 7 • Baseline to 36 months of treatment
|
|
Nervous system disorders
TREMOR
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
5.4%
9/166 • Number of events 9 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
RAPID EYE MOVEMENTS SLEEP ABNORMAL
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
4.8%
8/166 • Number of events 9 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.3%
9/170 • Number of events 9 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.5%
6/170 • Number of events 6 • Baseline to 36 months of treatment
|
4.2%
7/166 • Number of events 7 • Baseline to 36 months of treatment
|
|
Nervous system disorders
DYSTONIA
|
4.7%
8/170 • Number of events 8 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
2.9%
5/170 • Number of events 9 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.5%
6/170 • Number of events 6 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
General disorders
CHEST PAIN
|
3.5%
6/170 • Number of events 7 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
2.9%
5/170 • Number of events 6 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Infections and infestations
INFLUENZA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
4.8%
8/166 • Number of events 8 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.5%
6/170 • Number of events 7 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Infections and infestations
DIVERTICULITIS
|
2.9%
5/170 • Number of events 6 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
LACERATION
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Vascular disorders
HYPOTENSION
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Nervous system disorders
PARAESTHESIA
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Eye disorders
VISION BLURRED
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Metabolism and nutrition disorders
ABNORMAL LOSS OF WEIGHT
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
3.5%
6/170 • Number of events 6 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Investigations
BLOOD CREATININE INCREASED
|
4.1%
7/170 • Number of events 7 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
4.1%
7/170 • Number of events 7 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
3.5%
6/170 • Number of events 6 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Nervous system disorders
SCIATICA
|
2.4%
4/170 • Number of events 6 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Ear and labyrinth disorders
VERTIGO
|
1.2%
2/170 • Number of events 3 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Cardiac disorders
PALPITATIONS
|
3.5%
6/170 • Number of events 6 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Vascular disorders
FLUSHING
|
4.1%
7/170 • Number of events 8 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Nervous system disorders
BRADYKINESIA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Eye disorders
DRY EYE
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
HALLUCINATION
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
General disorders
PAIN
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
PLANTAR FASCIITIS
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
PROTEINURIA
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
3.0%
5/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
VOMITING
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.8%
3/170 • Number of events 4 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Vascular disorders
HOT FLUSH
|
2.9%
5/170 • Number of events 6 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
1.2%
2/170 • Number of events 3 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Cardiac disorders
TACHYCARDIA
|
2.4%
4/170 • Number of events 5 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Nervous system disorders
AMNESIA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/170 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/170 • Baseline to 36 months of treatment
|
3.6%
6/166 • Number of events 6 • Baseline to 36 months of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Nervous system disorders
SYNCOPE
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Infections and infestations
TOOTH ABSCESS
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
2.4%
4/170 • Number of events 4 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.2%
2/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
General disorders
IRRITABILITY
|
1.2%
2/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
2.9%
5/170 • Number of events 6 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
1.8%
3/170 • Number of events 4 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
ABNORMAL DREAMS
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Nervous system disorders
COGNITIVE DISORDER
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
2.9%
5/170 • Number of events 5 • Baseline to 36 months of treatment
|
0.00%
0/166 • Baseline to 36 months of treatment
|
|
Infections and infestations
EYE INFECTION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Infections and infestations
HERPES ZOSTER
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 5 • Baseline to 36 months of treatment
|
|
Infections and infestations
PNEUMONIA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
General disorders
ASTHENIA
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/170 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.2%
2/170 • Number of events 2 • Baseline to 36 months of treatment
|
1.2%
2/166 • Number of events 2 • Baseline to 36 months of treatment
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
1.8%
3/170 • Number of events 3 • Baseline to 36 months of treatment
|
0.60%
1/166 • Number of events 1 • Baseline to 36 months of treatment
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/170 • Baseline to 36 months of treatment
|
2.4%
4/166 • Number of events 4 • Baseline to 36 months of treatment
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.59%
1/170 • Number of events 1 • Baseline to 36 months of treatment
|
1.8%
3/166 • Number of events 3 • Baseline to 36 months of treatment
|
Additional Information
David Oakes, PhD
University of Rochester Medical Center, Department of Biostatistics and Computational Biology
Phone: 5852752405
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place