Trial Outcomes & Findings for Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (NCT NCT03640312)
NCT ID: NCT03640312
Last Updated: 2025-01-03
Results Overview
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-01-03
Participant Flow
120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized
NA - all enrolled participants were randomized.
Participant milestones
| Measure |
QUARTET LDQT
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
6 Week Follow Up
|
32
|
28
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
QUARTET LDQT
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
Baseline Characteristics
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
Baseline characteristics by cohort
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Body Mass Index, kg/m^2
|
33 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
34 kg/m^2
STANDARD_DEVIATION 7.9 • n=7 Participants
|
34 kg/m^2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Heart rate, beats per minute
|
71.5 beats per minute
STANDARD_DEVIATION 10.0 • n=5 Participants
|
71.7 beats per minute
STANDARD_DEVIATION 11.7 • n=7 Participants
|
71.6 beats per minute
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
History of diabetes, n (%)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
History of smoking, n (%)
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
History of depression, n (%)
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Weekly alcohol use, n (%)
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Systolic Blood Pressure, mm Hg
|
137.6 mm Hg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
138.7 mm Hg
STANDARD_DEVIATION 10.8 • n=7 Participants
|
138.1 mm Hg
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Diastolic Blood Pressure, mm Hg
|
84.3 mm Hg
STANDARD_DEVIATION 9.6 • n=5 Participants
|
84.3 mm Hg
STANDARD_DEVIATION 11.5 • n=7 Participants
|
84.3 mm Hg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
52 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/Sub Saharan African
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Caucasian/Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Change in Mean Systolic Blood Pressure
|
-15.65 mm Hg
Interval -19.7 to -11.6
|
-10.87 mm Hg
Interval -15.24 to -6.5
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean automated office systolic blood pressure adjusted for baseline values.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
122.37 mm Hg
Interval 118.32 to 126.42
|
127.15 mm Hg
Interval 122.78 to 131.52
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Change in Mean Diastolic Blood Pressure
|
-11.60 mm Hg
Interval -14.16 to -9.04
|
-6.74 mm Hg
Interval -9.5 to -3.98
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean automated office diastolic blood pressure adjusted for baseline values.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Diastolic Blood Pressure
|
73.01 mm Hg
Interval 70.46 to 75.57
|
77.88 mm Hg
Interval 75.12 to 80.64
|
SECONDARY outcome
Timeframe: 6 and 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Proportion of patients with hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg).
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Proportion of Patients With Hypertension Control
6 weeks
|
0.6875 proportion of participants
|
0.3929 proportion of participants
|
|
Proportion of Patients With Hypertension Control
12 weeks
|
0.6667 proportion of participants
|
0.5769 proportion of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Number of patients requiring step-up treatment.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Number of Patients Requiring Step up Treatment
|
6 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg).
Outcome measures
| Measure |
QUARTET LDQT
n=30 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=26 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Proportion of Patients With Adverse Event Free Hypertension Control
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Medication adherence defined by objective pill counts
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Medication Adherence
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data are available on only 28 participants in the intervention group for the mental health T score.
Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline.
Outcome measures
| Measure |
QUARTET LDQT
n=29 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=25 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Health-related Quality of Life
Change in Physical Health T score (PROMIS)
|
1.28 score on a scale
Standard Deviation 7.48
|
5.99 score on a scale
Standard Deviation 6.97
|
|
Health-related Quality of Life
Change in Mental Health T score (PROMIS)
|
2.86 score on a scale
Standard Deviation 6.25
|
2.76 score on a scale
Standard Deviation 7.63
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Change in Mean Systolic Blood Pressure
|
-15.65 mm Hg
Interval -19.7 to -11.6
|
-10.87 mm Hg
Interval -15.24 to -6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All randomized participants
Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All randomized participants
Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Potentially Related Adverse Events
|
8 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksRate of pre-specified adverse events that are known side effects of active ingredients at the participant level.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Rate of Adverse Events of Special Interest
|
16 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in continuous serum potassium.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Change in Serum Potassium
|
0.01 mEq/L
Standard Deviation 0.42
|
0.02 mEq/L
Standard Deviation 0.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in continuous serum sodium.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Change in Serum Sodium
|
-0.81 mEq/L
Standard Deviation 2.00
|
-0.15 mEq/L
Standard Deviation 2.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change (from baseline) in continuous blood urea nitrogen.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Change in Blood Urea Nitrogen
|
0.38 mg/dL
Standard Deviation 4.23
|
-0.40 mg/dL
Standard Deviation 7.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
Mean change in continuous serum creatinine.
Outcome measures
| Measure |
QUARTET LDQT
n=32 Participants
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 Participants
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Mean Change in Serum Creatinine
|
-0.04 mg/dL
Standard Deviation 0.11
|
-0.04 mg/dL
Standard Deviation 0.11
|
Adverse Events
QUARTET LDQT
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Candesartan
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QUARTET LDQT
n=32 participants at risk
Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 participants at risk
Patients randomized to the comparison arm will take a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Chest Pain
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
Other adverse events
| Measure |
QUARTET LDQT
n=32 participants at risk
Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
|
Candesartan
n=30 participants at risk
Patients randomized to the comparison arm will take a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Eye disorders
Eye pruritis
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
3/32 • Number of events 3 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
6.7%
2/30 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
6.7%
2/30 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Throat irritation
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Dry throat
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Feeling Hot
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 3 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Peripheral swelling
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
10.0%
3/30 • Number of events 3 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Chest Pain
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Asthenia
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Investigations
Blood glucose increased
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Investigations
Heart rate irregular
|
6.2%
2/32 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
6.7%
2/30 • Number of events 3 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps/spasms
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Nervous system disorders
Headache
|
15.6%
5/32 • Number of events 6 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
6.7%
2/30 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Nervous system disorders
Vision blurred
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Nervous system disorders
Hypoaesthesia
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
10.0%
3/30 • Number of events 3 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.4%
3/32 • Number of events 4 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
6.7%
2/30 • Number of events 2 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration Abnormal
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
0.00%
0/30 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
|
Vascular disorders
Dizziness
|
12.5%
4/32 • Number of events 4 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
3.3%
1/30 • Number of events 1 • 12 weeks
Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place