Trial Outcomes & Findings for Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo (NCT NCT02240693)
NCT ID: NCT02240693
Last Updated: 2018-11-28
Results Overview
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-11-28
Participant Flow
A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's Disease
For this trial, patients were randomised at 36 sites in 11 countries. Following an initial Screening Visit and a single blinded 2-week placebo run-in period, patients who qualified according to the in- and exclusion criteria were randomised to one of the five treatment groups
Participant milestones
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
21
|
21
|
43
|
|
Overall Study
COMPLETED
|
22
|
21
|
17
|
20
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Other than specified
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo
Baseline characteristics by cohort
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=22 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=21 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=21 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=21 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=43 Participants
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
72.3 years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
74.1 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
73.3 years
STANDARD_DEVIATION 5.1 • n=27 Participants
|
71.9 years
STANDARD_DEVIATION 6.0 • n=483 Participants
|
72.2 years
STANDARD_DEVIATION 6.5 • n=36 Participants
|
72.7 years
STANDARD_DEVIATION 6.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
71 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
128 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Neuropsychological Test Battery (NTB) Total
|
0.07 z-score
STANDARD_DEVIATION 0.70 • n=93 Participants
|
0.02 z-score
STANDARD_DEVIATION 0.75 • n=4 Participants
|
-0.02 z-score
STANDARD_DEVIATION 0.72 • n=27 Participants
|
-0.02 z-score
STANDARD_DEVIATION 0.61 • n=483 Participants
|
-0.03 z-score
STANDARD_DEVIATION 0.63 • n=36 Participants
|
-0.00 z-score
STANDARD_DEVIATION 0.66 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: The full analysis set (FAS) included all randomised patients who were treated with at least one dose of trial medication and had a baseline and at least one post-baseline on-treatment efficacy assessment. Observed cases (OC)
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=20 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=19 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=16 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=18 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=73 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
n=39 Participants
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
|
0.35 z-score
Standard Error 0.061
|
0.20 z-score
Standard Error 0.063
|
0.26 z-score
Standard Error 0.065
|
0.32 z-score
Standard Error 0.064
|
0.29 z-score
Standard Error 0.031
|
0.27 z-score
Standard Error 0.043
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS observed cases for pooled groups of these twin trials
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=67 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=63 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=67 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=63 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=260 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
n=122 Participants
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Twin Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)
|
0.20 z-score
Standard Error 0.046
|
0.19 z-score
Standard Error 0.048
|
0.19 z-score
Standard Error 0.046
|
0.10 z-score
Standard Error 0.047
|
0.17 z-score
Standard Error 0.025
|
0.19 z-score
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS- Observed cases
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=19 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=18 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=20 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=17 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=37 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living for Patients With Mild Cognitive Impairment) Total Score After 12-week Treatment
|
0.24 Unit on scale
Standard Error 0.896
|
1.79 Unit on scale
Standard Error 0.921
|
-0.10 Unit on scale
Standard Error 0.875
|
0.80 Unit on scale
Standard Error 0.947
|
0.38 Unit on scale
Standard Error 0.642
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS- Observed cases
The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=21 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=19 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=16 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=18 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=40 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
|
0.0 Unit on scale
Standard Error 0.19
|
0.4 Unit on scale
Standard Error 0.20
|
-0.1 Unit on scale
Standard Error 0.22
|
0.1 Unit on scale
Standard Error 0.21
|
0.1 Unit on scale
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS- Observed cases
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=19 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=17 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=19 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=19 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=38 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
|
0.98 Unit on scale
Standard Error 0.885
|
0.62 Unit on scale
Standard Error 0.935
|
0.12 Unit on scale
Standard Error 0.875
|
-1.27 Unit on scale
Standard Error 0.875
|
1.24 Unit on scale
Standard Error 0.619
|
—
|
Adverse Events
BI 409306 10 Milligram (mg) Once Daily (QD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 409306 25 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 409306 50 mg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BI 409306 25 mg Twice Daily (BID)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Matching BI 409306
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=22 participants at risk
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=21 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=21 participants at risk
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=21 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=43 participants at risk
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
2.3%
1/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.8%
1/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
Other adverse events
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=22 participants at risk
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=21 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=21 participants at risk
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=21 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=43 participants at risk
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
9.1%
2/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
14.3%
3/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.8%
1/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.8%
1/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
14.3%
3/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.8%
1/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
9.5%
2/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
9.5%
2/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
19.0%
4/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
14.3%
3/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.7%
2/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
9.5%
2/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Vascular disorders
Hypertension
|
9.1%
2/22 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
19.0%
4/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/21 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
9.3%
4/43 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER