Hypertension
Conditions
Keywords
Hypertension, Blood Pressure
Brief summary
To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT) will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension. Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.
Detailed description
This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP\>130 mmHg or DBP\>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar. The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population. While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.
Interventions
DRUGQUARTET LDQT
Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
DRUGCandesartan
Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
Sponsors
ACCESS Community Health Network
University of Sydney
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) * Spanish or English speaker. * Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse). * Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks. * Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose. * Research grade blood pressure measurement (baseline mean) SBP\>= 115 mmHg and DBP \>= 60 mmHg
Exclusion criteria
* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol. * Previous diagnosis of coronary artery disease, stroke, or heart failure. * Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g) * Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L). * Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods). * Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments. * Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible. * Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy. * Inability or unwillingness to provide written informed consent. * Unable to complete study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Systolic Blood Pressure | 12 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Diastolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values. |
| Mean Diastolic Blood Pressure | 6 weeks | Mean automated office diastolic blood pressure adjusted for baseline values. |
| Proportion of Patients With Hypertension Control | 6 and 12 weeks | Proportion of patients with hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg). |
| Number of Patients Requiring Step up Treatment | 6 weeks | Number of patients requiring step-up treatment. |
| Proportion of Patients With Adverse Event Free Hypertension Control | 12 weeks | Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg). |
| Medication Adherence | 12 weeks | Medication adherence defined by objective pill counts |
| Health-related Quality of Life | 12 weeks | 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. |
| Change in Mean Systolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
| Mean Systolic Blood Pressure | 6 weeks | Mean automated office systolic blood pressure adjusted for baseline values. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events of Special Interest | 12 weeks | Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level. |
| Mean Change in Serum Potassium | 12 weeks | Mean change (from baseline) in continuous serum potassium. |
| Mean Change in Serum Sodium | 12 weeks | Mean change (from baseline) in continuous serum sodium. |
| Mean Change in Blood Urea Nitrogen | 12 weeks | Mean change (from baseline) in continuous blood urea nitrogen. |
| Mean Change in Serum Creatinine | 12 weeks | Mean change in continuous serum creatinine. |
| Percentage of Participants With Potentially Related Adverse Events | 12 weeks | 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. |
| Percentage of Participants With Serious Adverse Events (SAEs) | 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
NA - all enrolled participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 30 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 |
Baseline characteristics
| Characteristic | QUARTET LDQT | Candesartan | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12.6 | 52 years STANDARD_DEVIATION 10.5 | 52 years STANDARD_DEVIATION 11.5 |
| Body Mass Index, kg/m^2 | 33 kg/m^2 STANDARD_DEVIATION 6.9 | 34 kg/m^2 STANDARD_DEVIATION 7.9 | 34 kg/m^2 STANDARD_DEVIATION 7.3 |
| Diastolic Blood Pressure, mm Hg | 84.3 mm Hg STANDARD_DEVIATION 9.6 | 84.3 mm Hg STANDARD_DEVIATION 11.5 | 84.3 mm Hg STANDARD_DEVIATION 10.5 |
| Heart rate, beats per minute | 71.5 beats per minute STANDARD_DEVIATION 10 | 71.7 beats per minute STANDARD_DEVIATION 11.7 | 71.6 beats per minute STANDARD_DEVIATION 10.8 |
| History of depression, n (%) | 7 Participants | 9 Participants | 16 Participants |
| History of diabetes, n (%) | 10 Participants | 7 Participants | 17 Participants |
| History of smoking, n (%) | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/Sub Saharan African | 4 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 24 Participants | 21 Participants | 45 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White/Caucasian/Other | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
| Systolic Blood Pressure, mm Hg | 137.6 mm Hg STANDARD_DEVIATION 11.8 | 138.7 mm Hg STANDARD_DEVIATION 10.8 | 138.1 mm Hg STANDARD_DEVIATION 11.2 |
| Weekly alcohol use, n (%) | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 20 / 32 | 14 / 30 |
| serious Total, serious adverse events | 2 / 32 | 0 / 30 |
Outcome results
Primary
Change in Mean Systolic Blood Pressure
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| QUARTET LDQT | Change in Mean Systolic Blood Pressure | -15.65 mm Hg |
| Candesartan | Change in Mean Systolic Blood Pressure | -10.87 mm Hg |
p-value: 0.11495% CI: [-10.74, 1.18]Mixed Models Analysis
Secondary
Change in Mean Diastolic Blood Pressure
Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| QUARTET LDQT | Change in Mean Diastolic Blood Pressure | -11.60 mm Hg |
| Candesartan | Change in Mean Diastolic Blood Pressure | -6.74 mm Hg |
Comparison: Adjusted for baseline diastolic blood pressure.p-value: 0.01295% CI: [-8.62, -1.11]Mixed Models Analysis
Secondary
Change in Mean Systolic Blood Pressure
Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| QUARTET LDQT | Change in Mean Systolic Blood Pressure | -15.65 mm Hg |
| Candesartan | Change in Mean Systolic Blood Pressure | -10.87 mm Hg |
Comparison: Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.p-value: 0.11495% CI: [-10.74, 1.182]Mixed Models Analysis
Secondary
Health-related Quality of Life
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.
Time frame: 12 weeks
Population: Data are available on only 28 participants in the intervention group for the mental health T score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QUARTET LDQT | Health-related Quality of Life | Change in Physical Health T score (PROMIS) | 1.28 score on a scale | Standard Deviation 7.48 |
| QUARTET LDQT | Health-related Quality of Life | Change in Mental Health T score (PROMIS) | 2.86 score on a scale | Standard Deviation 6.25 |
| Candesartan | Health-related Quality of Life | Change in Physical Health T score (PROMIS) | 5.99 score on a scale | Standard Deviation 6.97 |
| Candesartan | Health-related Quality of Life | Change in Mental Health T score (PROMIS) | 2.76 score on a scale | Standard Deviation 7.63 |
Comparison: Statistical test for difference in Physical Health T Scorep-value: 0.0995% CI: [-7.49, 0.59]ANCOVA
Comparison: Statistical test for difference in Mental Health T Scorep-value: 0.7795% CI: [-3.22, 4.32]ANCOVA
Secondary
Mean Diastolic Blood Pressure
Mean automated office diastolic blood pressure adjusted for baseline values.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| QUARTET LDQT | Mean Diastolic Blood Pressure | 73.01 mm Hg |
| Candesartan | Mean Diastolic Blood Pressure | 77.88 mm Hg |
p-value: 0.01295% CI: [-8.62, -1.11]Mixed Models Analysis
Secondary
Mean Systolic Blood Pressure
Mean automated office systolic blood pressure adjusted for baseline values.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| QUARTET LDQT | Mean Systolic Blood Pressure | 122.37 mm Hg |
| Candesartan | Mean Systolic Blood Pressure | 127.15 mm Hg |
p-value: 0.11495% CI: [-10.74, 1.18]Mixed Models Analysis
Secondary
Medication Adherence
Medication adherence defined by objective pill counts
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Medication Adherence | 21 Participants |
| Candesartan | Medication Adherence | 21 Participants |
Comparison: Logistic regression model adjusting for baseline systolic and diastolic blood pressure.p-value: 0.43795% CI: [0.21, 1.98]Regression, Logistic
Secondary
Number of Patients Requiring Step up Treatment
Number of patients requiring step-up treatment.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Number of Patients Requiring Step up Treatment | 6 Participants |
| Candesartan | Number of Patients Requiring Step up Treatment | 16 Participants |
Comparison: Logistic regression model adjusting for baseline systolic and diastolic blood pressure.p-value: 0.00395% CI: [0.03, 0.48]Regression, Logistic
Secondary
Proportion of Patients With Adverse Event Free Hypertension Control
Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg).
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Proportion of Patients With Adverse Event Free Hypertension Control | 6 Participants |
| Candesartan | Proportion of Patients With Adverse Event Free Hypertension Control | 9 Participants |
Comparison: Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.p-value: 0.7195% CI: [0.24, 2.69]Mixed Models Analysis
Secondary
Proportion of Patients With Hypertension Control
Proportion of patients with hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg).
Time frame: 6 and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QUARTET LDQT | Proportion of Patients With Hypertension Control | 6 weeks | 0.6875 proportion of participants |
| QUARTET LDQT | Proportion of Patients With Hypertension Control | 12 weeks | 0.6667 proportion of participants |
| Candesartan | Proportion of Patients With Hypertension Control | 6 weeks | 0.3929 proportion of participants |
| Candesartan | Proportion of Patients With Hypertension Control | 12 weeks | 0.5769 proportion of participants |
p-value: 0.07795% CI: [0.91, 6.35]Mixed Models Analysis
Other Pre-specified
Mean Change in Blood Urea Nitrogen
Mean change (from baseline) in continuous blood urea nitrogen.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QUARTET LDQT | Mean Change in Blood Urea Nitrogen | 0.38 mg/dL | Standard Deviation 4.23 |
| Candesartan | Mean Change in Blood Urea Nitrogen | -0.40 mg/dL | Standard Deviation 7.11 |
p-value: 0.9495% CI: [-1.84, 1.99]Mixed Models Analysis
Other Pre-specified
Mean Change in Serum Creatinine
Mean change in continuous serum creatinine.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QUARTET LDQT | Mean Change in Serum Creatinine | -0.04 mg/dL | Standard Deviation 0.11 |
| Candesartan | Mean Change in Serum Creatinine | -0.04 mg/dL | Standard Deviation 0.11 |
p-value: 0.5595% CI: [-0.07, 0.04]Mixed Models Analysis
Other Pre-specified
Mean Change in Serum Potassium
Mean change (from baseline) in continuous serum potassium.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QUARTET LDQT | Mean Change in Serum Potassium | 0.01 mEq/L | Standard Deviation 0.42 |
| Candesartan | Mean Change in Serum Potassium | 0.02 mEq/L | Standard Deviation 0.31 |
p-value: 0.5695% CI: [-0.24, 0.13]Mixed Models Analysis
Other Pre-specified
Mean Change in Serum Sodium
Mean change (from baseline) in continuous serum sodium.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QUARTET LDQT | Mean Change in Serum Sodium | -0.81 mEq/L | Standard Deviation 2 |
| Candesartan | Mean Change in Serum Sodium | -0.15 mEq/L | Standard Deviation 2.66 |
p-value: 0.1295% CI: [-1.61, 0.19]Mixed Models Analysis
Other Pre-specified
Percentage of Participants With Potentially Related Adverse Events
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.
Time frame: 12 weeks
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Percentage of Participants With Potentially Related Adverse Events | 8 Participants |
| Candesartan | Percentage of Participants With Potentially Related Adverse Events | 3 Participants |
p-value: 0.2195% CI: [-0.33, 0.03]Chi-squared
Other Pre-specified
Percentage of Participants With Serious Adverse Events (SAEs)
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.
Time frame: 12 weeks
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Percentage of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Candesartan | Percentage of Participants With Serious Adverse Events (SAEs) | 0 Participants |
p-value: 0.4995% CI: [-0.15, 0.02]Fisher Exact
Other Pre-specified
Rate of Adverse Events of Special Interest
Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QUARTET LDQT | Rate of Adverse Events of Special Interest | 16 Participants |
| Candesartan | Rate of Adverse Events of Special Interest | 10 Participants |
p-value: 0.1895% CI: [-0.41, 0.08]Chi-squared