Trial Outcomes & Findings for An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension (NCT NCT02235909)
NCT ID: NCT02235909
Last Updated: 2025-02-25
Results Overview
Change in Seated Diastolic Blood Pressure from Week 6/Final visit of DB Phase to Week 8/Final Visit of the Withdrawal Phase, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
377 participants
Primary outcome timeframe
From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
Results posted on
2025-02-25
Participant Flow
If the subject was taking antihypertensive medication, the subject was required a 14-day washout. The washout coincided with the Placebo Run-in. The Run-in Period consisted of two visits: Run-in, Day-14 (Visit 2); and Run-in, Day-1 (Visit 3), which only was required for subjects participating in the Ambulatory Blood Pressure Monitoring (ABPM) procedure. Participants who were enrolled in the study may have screen failed prior to first dosing with study drug, described above.
Participant milestones
| Measure |
Active Comparator: Double Blind Phase: Losartan
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Starting at Losartan 25/50 and force titrated to 50/100 mg daily at Week 2.
|
Experimental: Double-blind: Azilsartan Medoxomil - Low Dose
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil Low-dose (AZM-L), 10 mg once daily.
|
Experimental: Double-blind: Azilsartan Medoxomil - Medium Dose
6-week, double-blind (DB), randomized, treatment phase (DB Phase), Azilsartan medoxomil Medium-dose (AZM-M), 20 mg once daily at Week 2.
|
Experimental: Double-blind: Azilsartan Medoxomil - High Dose
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil High-dose (AZM-H), 40 mg AZM-M
|
Placebo Comparator: Withdrawal Phase: PLACEBO
Placebo Arm In the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
|
Active Comparator: Withdrawal Phase: Losartan 50 mg
Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
|
Active Comparator: WITHDRAWAL Phase: Azilsartan Medoxomil LOW-dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil low dose) that was taken in Double blind OR to be switched to placebo.
|
Experimental: WITHDRAWAL Azilsartan Medoxomil - Medium Dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil MEDIUM dose) that was taken in Double blind OR to be switched to placebo.
|
Experimental: WITHDRAWAL Azilsartan Medoxomil - High Dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil HIGH dose) that was taken in Double blind OR to be switched to placebo.
|
Azilsartan Medoxomil Alone
A subset of subjects taking AZM (10, 20, 40, or 80 mg) alone
|
AZM Plus
A subset of subjects taking AZM (10, 20, 40, or 80 mg) plus additional antihypertensives as needed
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Phase
STARTED
|
53
|
52
|
56
|
54
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
47
|
52
|
53
|
51
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
6
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Withdrawal Phase
STARTED
|
0
|
0
|
0
|
0
|
103
|
23
|
26
|
26
|
25
|
0
|
0
|
|
Withdrawal Phase
COMPLETED
|
0
|
0
|
0
|
0
|
102
|
22
|
26
|
24
|
23
|
0
|
0
|
|
Withdrawal Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
2
|
0
|
0
|
|
Open Label
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
156
|
41
|
|
Open Label
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
144
|
40
|
|
Open Label
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
Baseline characteristics by cohort
| Measure |
AZM-H
n=54 Participants
Subjects who received AZM-H
|
AZM-M
n=56 Participants
Subjects who received AZM-M
|
AZM-L
n=52 Participants
Subjects who received AZM-L
|
Losartan
n=53 Participants
Subjects who received Losartan
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
13.4 years
STANDARD_DEVIATION 2.92 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 3.18 • n=4 Participants
|
13.4 years
STANDARD_DEVIATION 3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Weight (kg)
|
68.97 kilogram
STANDARD_DEVIATION 24.744 • n=5 Participants
|
66.65 kilogram
STANDARD_DEVIATION 24.627 • n=7 Participants
|
72.53 kilogram
STANDARD_DEVIATION 28.556 • n=5 Participants
|
69.00 kilogram
STANDARD_DEVIATION 26.235 • n=4 Participants
|
69.23 kilogram
STANDARD_DEVIATION 25.952 • n=21 Participants
|
PRIMARY outcome
Timeframe: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal PhasePopulation: Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Change in Seated Diastolic Blood Pressure from Week 6/Final visit of DB Phase to Week 8/Final Visit of the Withdrawal Phase, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Outcome measures
| Measure |
Pooled Placebo
n=79 Participants
Subjects who received Placebo
|
Pooled AZM
n=77 Participants
Subjects who received AZM
|
|---|---|---|
|
Change in Seated Diastolic Blood Pressure Between AZM and Placebo
|
3.9 mmHg
Standard Deviation 8
|
-1.6 mmHg
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal PhasePopulation: Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Change in Trough Seated Systolic Blood Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Outcome measures
| Measure |
Pooled Placebo
n=79 Participants
Subjects who received Placebo
|
Pooled AZM
n=77 Participants
Subjects who received AZM
|
|---|---|---|
|
Change in Trough Seated Systolic Blood Pressure
|
4.4 mmHg
Standard Deviation 9.96
|
-2.3 mmHg
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal PhasePopulation: Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Change in Mean Arterial Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Outcome measures
| Measure |
Pooled Placebo
n=79 Participants
Subjects who received Placebo
|
Pooled AZM
n=77 Participants
Subjects who received AZM
|
|---|---|---|
|
Change in Mean Arterial Pressure
|
4.1 mmHg
Standard Deviation 7.43
|
-1.8 mmHg
Standard Deviation 6.63
|
Adverse Events
Placebo Run-In
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Losartan (Double-Blind Phase)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
AZM-L (Double-Blind Phase)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
AZM-M (Double-Blind Phase)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
AZM-H (Double-Blind Phase)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Withdrawal Phase)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Losartan (Withdrawal Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZM-L (Withdrawal Phase)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
AZM-M (Withdrawal Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZM-H (Withdrawal Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azilsartan Medoxomil Alone
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Azilsartan Medoxomil PLUS
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Run-In
n=289 participants at risk
Placebo run-in phase
|
Losartan (Double-Blind Phase)
n=53 participants at risk
Subjects who received Losartan (Double-Blind Phase)
|
AZM-L (Double-Blind Phase)
n=52 participants at risk
Subjects who received AZM-L (Double-Blind Phase)
|
AZM-M (Double-Blind Phase)
n=56 participants at risk
Subjects who received AZM-M (Double-Blind Phase)
|
AZM-H (Double-Blind Phase)
n=54 participants at risk
Subjects who received AZM-H (Double-Blind Phase)
|
Placebo (Withdrawal Phase)
n=103 participants at risk
Subjects who received Placebo (Withdrawal Phase)
|
Losartan (Withdrawal Phase)
n=23 participants at risk
Subjects who received Losartan (Withdrawal Phase)
|
AZM-L (Withdrawal Phase)
n=26 participants at risk
Subjects who received AZM-L (Withdrawal Phase)
|
AZM-M (Withdrawal Phase)
n=26 participants at risk
Subjects who received AZM-M (Withdrawal Phase)
|
AZM-H (Withdrawal Phase)
n=25 participants at risk
Subjects who received AZM-H (Withdrawal Phase)
|
Azilsartan Medoxomil Alone
n=156 participants at risk
Subjects who receive only AZM
|
Azilsartan Medoxomil PLUS
n=41 participants at risk
Subjects who receive AZM and any additional antihypertensive therapies
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
1.8%
1/56 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
2.4%
1/41 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
1.9%
1/53 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
1.9%
1/53 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
1.9%
1/52 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
3.8%
1/26 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
2.4%
1/41 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Investigations
Blood pressure increased
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.64%
1/156 • Number of events 1 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
Other adverse events
| Measure |
Placebo Run-In
n=289 participants at risk
Placebo run-in phase
|
Losartan (Double-Blind Phase)
n=53 participants at risk
Subjects who received Losartan (Double-Blind Phase)
|
AZM-L (Double-Blind Phase)
n=52 participants at risk
Subjects who received AZM-L (Double-Blind Phase)
|
AZM-M (Double-Blind Phase)
n=56 participants at risk
Subjects who received AZM-M (Double-Blind Phase)
|
AZM-H (Double-Blind Phase)
n=54 participants at risk
Subjects who received AZM-H (Double-Blind Phase)
|
Placebo (Withdrawal Phase)
n=103 participants at risk
Subjects who received Placebo (Withdrawal Phase)
|
Losartan (Withdrawal Phase)
n=23 participants at risk
Subjects who received Losartan (Withdrawal Phase)
|
AZM-L (Withdrawal Phase)
n=26 participants at risk
Subjects who received AZM-L (Withdrawal Phase)
|
AZM-M (Withdrawal Phase)
n=26 participants at risk
Subjects who received AZM-M (Withdrawal Phase)
|
AZM-H (Withdrawal Phase)
n=25 participants at risk
Subjects who received AZM-H (Withdrawal Phase)
|
Azilsartan Medoxomil Alone
n=156 participants at risk
Subjects who receive only AZM
|
Azilsartan Medoxomil PLUS
n=41 participants at risk
Subjects who receive AZM and any additional antihypertensive therapies
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Gastrointestinal disorders
Nasopharyngitis
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.7%
3/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.4%
3/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
3.7%
2/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
12.2%
5/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
9.6%
5/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.7%
2/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
14.6%
6/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.7%
3/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.4%
3/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.6%
3/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
5.8%
6/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.7%
2/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.1%
11/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/289 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/53 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/52 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/56 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/54 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/103 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/23 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/26 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/25 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
0.00%
0/156 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
7.3%
3/41 • 54 weeks
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60