Trial · NCT03640312
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
NCT03640312, Phase 2, Completed, Washington University School of Medicine; results first posted 2023-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension. Trials, record NCT03640312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03640312
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
- NCT number
- NCT03640312
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Hypertension
- Interventions
- QUARTET LDQT, Candesartan
- First posted
- 2018-08-21
- Last updated
- 2025-01-03
- Results first posted
- 2023-09-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Systolic Blood Pressure | 12 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
| Secondary | Mean Systolic Blood Pressure | 6 weeks | Mean automated office systolic blood pressure adjusted for baseline values. |
| Secondary | Change in Mean Diastolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values. |
| Secondary | Mean Diastolic Blood Pressure | 6 weeks | Mean automated office diastolic blood pressure adjusted for baseline values. |
| Secondary | 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). |
| Secondary | Number of Patients Requiring Step up Treatment | 6 weeks | Number of patients requiring step-up treatment. |
| Secondary | 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). |
| Secondary | Medication Adherence | 12 weeks | Medication adherence defined by objective pill counts |
| Secondary | 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. |
| Secondary | Change in Mean Systolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Systolic Blood Pressure | 12 weeks | 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. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Systolic Blood Pressure | 6 weeks | 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. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Diastolic Blood Pressure | 6 weeks | 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. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Diastolic Blood Pressure | 6 weeks | 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. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Patients With Hypertension Control | 6 and 12 weeks | 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 participants | NUMBER |
| SECONDARY | Number of Patients Requiring Step up Treatment | 6 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Adverse Event Free Hypertension Control | 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Medication Adherence | 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Health-related Quality of Life | 12 weeks | Data are available on only 28 participants in the intervention group for the mental health T score. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Systolic Blood Pressure | 6 weeks | 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. | mm Hg | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Systolic Blood Pressure | QUARTET LDQT | -15.65 | 95% Confidence Interval -19.70 to -11.60 | mm Hg | |
| Change in Mean Systolic Blood Pressure | Candesartan | -10.87 | 95% Confidence Interval -15.24 to -6.50 | mm Hg | |
| Mean Systolic Blood Pressure | QUARTET LDQT | 122.37 | 95% Confidence Interval 118.32 to 126.42 | mm Hg | |
| Mean Systolic Blood Pressure | Candesartan | 127.15 | 95% Confidence Interval 122.78 to 131.52 | mm Hg | |
| Change in Mean Diastolic Blood Pressure | QUARTET LDQT | -11.60 | 95% Confidence Interval -14.16 to -9.04 | mm Hg | |
| Change in Mean Diastolic Blood Pressure | Candesartan | -6.74 | 95% Confidence Interval -9.50 to -3.98 | mm Hg | |
| Mean Diastolic Blood Pressure | QUARTET LDQT | 73.01 | 95% Confidence Interval 70.46 to 75.57 | mm Hg | |
| Mean Diastolic Blood Pressure | Candesartan | 77.88 | 95% Confidence Interval 75.12 to 80.64 | mm Hg | |
| Proportion of Patients With Hypertension Control | QUARTET LDQT | 6 weeks | 0.6875 | proportion of participants | |
| Proportion of Patients With Hypertension Control | Candesartan | 6 weeks | 0.3929 | proportion of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QUARTET LDQT | 32 | |
| Overall Study | STARTED | Candesartan | 30 | |
| Overall Study | 6 Week Follow Up | QUARTET LDQT | 32 | |
| Overall Study | 6 Week Follow Up | Candesartan | 28 | |
| Overall Study | COMPLETED | QUARTET LDQT | 29 | |
| Overall Study | COMPLETED | Candesartan | 24 | |
| Overall Study | NOT COMPLETED | QUARTET LDQT | 3 | |
| Overall Study | NOT COMPLETED | Candesartan | 6 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | QUARTET LDQT | 1 | 32 | 1 |
| other | Vision blurred | Eye disorders | Candesartan | 1 | 30 | 1 |
| other | Palpitations | Cardiac disorders | QUARTET LDQT | 0 | 32 | 0 |
| other | Palpitations | Cardiac disorders | Candesartan | 1 | 30 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | QUARTET LDQT | 1 | 32 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Candesartan | 0 | 30 | 0 |
| other | Eye pruritis | Eye disorders | QUARTET LDQT | 1 | 32 | 1 |
| other | Eye pruritis | Eye disorders | Candesartan | 0 | 30 | 0 |
| other | Diarrhea | Gastrointestinal disorders | QUARTET LDQT | 3 | 32 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Candesartan | 2 | 30 | 2 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QUARTET LDQT | 0 | 32 |
| Total, all-cause mortality | Candesartan | 0 | 30 |
| Total, other adverse events | QUARTET LDQT | 20 | 32 |
| Total, other adverse events | Candesartan | 14 | 30 |
| Total, serious adverse events | QUARTET LDQT | 2 | 32 |
| Total, serious adverse events | Candesartan | 0 | 30 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QUARTET LDQT vs Candesartan: Rate of Adverse Events of Special Interest | Trial comparisons |
| QUARTET LDQT vs Candesartan: Proportion of Patients With Adverse Event Free Hypertension Control | Trial comparisons |
| QUARTET LDQT vs Candesartan: Percentage of Participants With Potentially Related Adverse Events | Trial comparisons |
| QUARTET LDQT vs Candesartan: Percentage of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| QUARTET LDQT vs Candesartan: Medication Adherence | Trial comparisons |
| QUARTET LDQT vs Candesartan: Number of Patients Requiring Step up Treatment | Trial comparisons |
| QUARTET LDQT vs Candesartan: deaths from any cause | Trial comparisons |
| QUARTET LDQT vs Candesartan: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03640312
GET https://conductscience.org/api/trials/v1/NCT03640312/results?page=2