Trial Outcomes & Findings for Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia (NCT NCT02517866)
NCT ID: NCT02517866
Last Updated: 2019-03-01
Results Overview
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
380 participants
Primary outcome timeframe
Week 12
Results posted on
2019-03-01
Participant Flow
Participants took part in the study at 34 investigative sites in Hong Kong, Taiwan and Thailand from 13 July 2015 to 25 November 2016.
Participants with a diagnosis of essential hypertension and type 2 diabetes mellitus (T2DM) were enrolled to receive azilsartan medoxomil at a starting dose of 40 mg increased to 80 mg if blood pressure of \<140/85 mmHg was not achieved at Week 6.
Participant milestones
| Measure |
Azilsartan Medoxomil (Switched)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Overall Study
STARTED
|
289
|
90
|
1
|
|
Overall Study
COMPLETED
|
269
|
84
|
1
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
0
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil (Switched)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
9
|
2
|
0
|
|
Overall Study
Significant Protocol Deviation
|
4
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Voluntary Withdrawal
|
2
|
2
|
0
|
|
Overall Study
Investigator Decision
|
2
|
1
|
0
|
|
Overall Study
Reason not specified
|
2
|
0
|
0
|
Baseline Characteristics
Here number analyzed is the number of participants who were evaluated for weight at baseline.
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil
n=380 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6.
|
|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.77 • n=380 Participants
|
|
Age, Customized
< 65 years old
|
221 Participants
n=380 Participants
|
|
Age, Customized
>=65 to <75 years old
|
159 Participants
n=380 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=380 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Asian
|
380 Participants
n=380 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
139 Participants
n=380 Participants
|
|
Region of Enrollment
Thailand
|
219 Participants
n=380 Participants
|
|
Region of Enrollment
Hong Kong
|
22 Participants
n=380 Participants
|
|
Height
|
161.1 cm
STANDARD_DEVIATION 9.57 • n=380 Participants
|
|
Weight
|
72.04 kg
STANDARD_DEVIATION 15.072 • n=374 Participants • Here number analyzed is the number of participants who were evaluated for weight at baseline.
|
|
Body Mass Index (BMI)
|
27.64 kg/m^2
STANDARD_DEVIATION 4.354 • n=374 Participants • Here number analyzed is the number of participants who were evaluated for BMI at baseline.
|
|
Smoking history
The participant has never smoked
|
279 Participants
n=380 Participants
|
|
Smoking history
The participant is an ex-smoker
|
75 Participants
n=380 Participants
|
|
Smoking history
The participant is a current smoker
|
26 Participants
n=380 Participants
|
|
Baseline Antihypertensive Treatment Status
Treated with ACE inhibitor or ARB before Baseline
|
202 participants
n=380 Participants
|
|
Baseline Antihypertensive Treatment Status
Treated with CCB before Baseline
|
112 participants
n=380 Participants
|
|
Baseline Antihypertensive Treatment Status
Treated with Thiazide before Baseline
|
30 participants
n=380 Participants
|
|
Baseline Antihypertensive Treatment Status
Other
|
121 participants
n=380 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
7.00 mmoL/moL
STANDARD_DEVIATION 0.875 • n=374 Participants • Only 374 participants were evaluated for this baseline characteristic.
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using last observation carried forward (LOCF) method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12
|
59.8 percentage of participants
Interval 43.4 to 63.08
|
65.9 percentage of participants
Interval 44.07 to 75.7
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil.
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=109 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg
Week 6
|
57.8 percentage of participants
Interval 45.36 to 71.12
|
—
|
—
|
|
Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg
Week 12
|
52.3 percentage of participants
Interval 39.75 to 65.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=193 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg
Week 6
|
63.7 percentage of participants
Interval 44.83 to 68.92
|
—
|
—
|
|
Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg
Week 12
|
63.7 percentage of participants
Interval 44.73 to 69.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.
At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=29 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg
Week 6
|
79.3 percentage of participants
Interval 45.97 to 89.46
|
—
|
—
|
|
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg
Week 12
|
86.2 percentage of participants
Interval 43.81 to 97.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil.
Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=109 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg
Week 6
|
26.6 percentage of participants
Interval 14.73 to 36.5
|
—
|
—
|
|
Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg
Week 12
|
27.5 percentage of participants
Interval 15.73 to 37.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=193 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg
Week 6
|
31.1 percentage of participants
Interval 10.05 to 33.2
|
—
|
—
|
|
Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg
Week 12
|
35.2 percentage of participants
Interval 12.18 to 37.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=29 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg
Week 6
|
41.4 percentage of participants
Interval 21.13 to 65.05
|
—
|
—
|
|
Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg
Week 12
|
51.7 percentage of participants
Interval 29.12 to 73.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12
|
68.8 percentage of participants
Interval 57.57 to 75.78
|
70.6 percentage of participants
Interval 52.49 to 83.94
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12
|
74.6 percentage of participants
Interval 64.86 to 81.66
|
81.2 percentage of participants
Interval 67.4 to 91.05
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With DBP <90 mmHg at Week 12
|
87.3 percentage of participants
Interval 85.11 to 95.34
|
87.1 percentage of participants
Interval 79.97 to 96.46
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With BP <130/80 mmHg at Week 12
|
33.7 percentage of participants
Interval 17.01 to 37.26
|
40.0 percentage of participants
Interval 18.66 to 48.66
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With SBP <130 mmHg at Week 12
|
41.3 percentage of participants
Interval 22.25 to 43.2
|
43.5 percentage of participants
Interval 20.17 to 50.31
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With DBP <80 mmHg at Week 12
|
57.6 percentage of participants
Interval 36.82 to 59.95
|
65.9 percentage of participants
Interval 41.33 to 75.07
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Percentage of Participants With BP <140/90 mmHg at Week 12
|
65.9 percentage of participants
Interval 52.51 to 71.04
|
68.2 percentage of participants
Interval 48.42 to 79.92
|
0.0 percentage of participants
CI was not calculated as there was only one participant in this group.
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=90 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Change From Baseline in Trough Sitting SBP at Week 12
|
-14.1 mmHg
Standard Error 1.39
|
-13.3 mmHg
Standard Error 2.12
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants
|
-7 mmHg
Standard Deviation NA
Standard deviation was not calculated as there was only one participant who was evaluated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=276 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
n=85 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Change From Baseline in DBP at Week 12
|
-4.9 mmHg
Standard Error 0.76
|
-5.7 mmHg
Standard Error 1.16
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.
At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Azilsartan Medoxomil (Switched)
n=1 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil.
|
Azilsartan Medoxomil (Add-On)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy.
|
Azilsartan Medoxomil (Treatment-Naïve)
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening.
|
|---|---|---|---|
|
Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants
|
20 mmHg
Standard Deviation NA
Standard deviation was not calculated as there was only one participant who was evaluated.
|
—
|
—
|
Adverse Events
Before Week 6 Azilsartan Medoxomil 40 mg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
After Week 6 Azilsartan Medoxomil 40 mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
After Week 6 Azilsartan Medoxomil 80 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Before Week 6 Azilsartan Medoxomil 40 mg
n=380 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 6 weeks.
|
After Week 6 Azilsartan Medoxomil 40 mg
n=258 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for Week 6 up to Week 12.
|
After Week 6 Azilsartan Medoxomil 80 mg
n=97 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, once, daily, for Week 6 up to Week 12.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.39%
1/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Cardiac disorders
Cardiac failure
|
0.26%
1/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
1.0%
1/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
1.0%
1/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.39%
1/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.26%
1/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.39%
1/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
1.0%
1/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.26%
1/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
|
Vascular disorders
Hypotension
|
0.26%
1/380 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/258 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
0.00%
0/97 • From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
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. Adverse Events are reported as per dose received.
|
Other adverse events
Adverse event data not reported
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