Trial Outcomes & Findings for Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension (NCT NCT02203916)
NCT ID: NCT02203916
Last Updated: 2016-12-19
Results Overview
The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2016-12-19
Participant Flow
Participants took part in the study at 29 investigative sites in Korea from 12 July 2014 to 03 February 2016.
Participants with a diagnosis of essential hypertension were randomized at a ratio of 2:2:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, 80 mg or placebo. One participant in the 80 mg group was randomized twice, counted once in the randomized set, and is excluded from the Full Analysis Set and Safety Analysis Set.
Participant milestones
| Measure |
Placebo
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
132
|
131
|
|
Overall Study
Full Analysis Set (FAS)
|
65
|
132
|
130
|
|
Overall Study
Safety Analysis Set (SAS)
|
65
|
132
|
130
|
|
Overall Study
COMPLETED
|
57
|
122
|
120
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
1
|
3
|
2
|
|
Overall Study
Major Protocol Deviation
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Voluntary Withdrawal
|
3
|
3
|
8
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
2
|
1
|
Baseline Characteristics
Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=132 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=130 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Overall Study
|
58.8 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 10.97 • n=4 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Gender
Male
|
51 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
65 participants
n=5 Participants
|
132 participants
n=7 Participants
|
130 participants
n=5 Participants
|
327 participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
65 participants
n=5 Participants
|
132 participants
n=7 Participants
|
130 participants
n=5 Participants
|
327 participants
n=4 Participants
|
|
Height
|
166.1 cm
STANDARD_DEVIATION 8.43 • n=5 Participants
|
164.8 cm
STANDARD_DEVIATION 9.09 • n=7 Participants
|
165.6 cm
STANDARD_DEVIATION 8.00 • n=5 Participants
|
165.4 cm
STANDARD_DEVIATION 8.53 • n=4 Participants
|
|
Weight
|
70.85 kg
STANDARD_DEVIATION 9.892 • n=5 Participants
|
70.97 kg
STANDARD_DEVIATION 12.636 • n=7 Participants
|
70.32 kg
STANDARD_DEVIATION 13.070 • n=5 Participants
|
70.69 kg
STANDARD_DEVIATION 12.291 • n=4 Participants
|
|
Body Mass Index (BMI)
|
25.64 kg/m^2
STANDARD_DEVIATION 2.653 • n=5 Participants
|
26.02 kg/m^2
STANDARD_DEVIATION 3.272 • n=7 Participants
|
25.50 kg/m^2
STANDARD_DEVIATION 3.460 • n=5 Participants
|
25.74 kg/m^2
STANDARD_DEVIATION 3.237 • n=4 Participants
|
|
Smoking Classification
Never smoked
|
29 participants
n=5 Participants
|
71 participants
n=7 Participants
|
65 participants
n=5 Participants
|
165 participants
n=4 Participants
|
|
Smoking Classification
Current smoker
|
12 participants
n=5 Participants
|
22 participants
n=7 Participants
|
26 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Smoking Classification
Ex-smoker
|
24 participants
n=5 Participants
|
39 participants
n=7 Participants
|
39 participants
n=5 Participants
|
102 participants
n=4 Participants
|
|
Female Reproductive Status
Postmenopausal
|
9 participants
n=5 Participants
|
28 participants
n=7 Participants
|
24 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Female Reproductive Status
Surgically Sterile
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Female Reproductive Status
Of Childbearing Potential
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Estimated Glomerular Filtration Rate(eGFR)
|
85.72 mL/min/1.73m^2
STANDARD_DEVIATION 14.798 • n=5 Participants
|
87.44 mL/min/1.73m^2
STANDARD_DEVIATION 18.393 • n=7 Participants
|
88.68 mL/min/1.73m^2
STANDARD_DEVIATION 18.443 • n=5 Participants
|
87.59 mL/min/1.73m^2
STANDARD_DEVIATION 17.740 • n=4 Participants
|
|
Diabetes Status
Yes
|
4 participants
n=5 Participants
|
21 participants
n=7 Participants
|
13 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Diabetes Status
No
|
61 participants
n=5 Participants
|
111 participants
n=7 Participants
|
117 participants
n=5 Participants
|
289 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).
The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.
Outcome measures
| Measure |
Placebo
n=63 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=127 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=129 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)
|
-8.776 mmHg
Standard Error 2.0039
|
-22.093 mmHg
Standard Error 1.4117
|
-23.731 mmHg
Standard Error 1.4017
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).
The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.
Outcome measures
| Measure |
Placebo
n=63 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=127 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=129 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)
|
-2.6 mmHg
Standard Deviation 8.60
|
-10.7 mmHg
Standard Deviation 10.12
|
-11.6 mmHg
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).
Clinic DBP response is defined as clinic DBP \<90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.
Outcome measures
| Measure |
Placebo
n=63 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=127 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=129 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Clinic DBP Response at Week 6
|
42.9 percentage of participants
|
83.5 percentage of participants
|
85.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).
SBP response is defined as clinic SBP \<140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.
Outcome measures
| Measure |
Placebo
n=63 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=127 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=129 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Clinic SBP Response at Week 6
|
38.1 percentage of participants
|
63.0 percentage of participants
|
65.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).
Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP \<90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP \<140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.
Outcome measures
| Measure |
Placebo
n=63 Participants
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=127 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=129 Participants
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6
|
25.4 percentage of participants
|
62.2 percentage of participants
|
65.9 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Azilsartan Medoxomil 40 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Azilsartan Medoxomil 80 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=132 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=130 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.00%
0/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.77%
1/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.00%
0/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.77%
1/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.00%
0/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.77%
1/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.00%
0/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.77%
1/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 40 mg
n=132 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
|
Azilsartan Medoxomil 80 mg
n=130 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
2.3%
3/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
5.4%
7/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
1.5%
2/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
3.1%
4/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
3.1%
2/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
2.3%
3/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
1.5%
2/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/65 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.76%
1/132 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
0.77%
1/130 • Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data is presented for the Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER