Generated Narrative: Composition 370504 version: 24; Last updated: 2025-08-18 13:22:42+0000; Language: en Profile: OutcomeMeasureReport ArtifactPublicationStatus: Active url: https://fevir.net/resources/Composition/370504 identifier: FEvIR Object Identifier/370504, FEvIR Linking Identifier/NCT03640312-outcome-measure-report status: Final type: Outcome Measure Report date: 2025-08-18 13:22:42+0000 author: [No author listed.] title: Outcome Measures Report for NCT03640312 custodian: Computable Publishing LLC RelatesTos - Type Target[x] * Cite As Outcome Measures Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370504. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370504. Computable resource at: https://fevir.net/resources/Composition/370504.
Outcome Measures Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370504. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370504. Computable resource at: https://fevir.net/resources/Composition/370504.
Change in Mean Systolic Blood Pressure at 12 weeks
Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)
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.
Posted
12 weeks
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.
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 at 12 weeks for QUARTET LDQT in NCT03640312
Change in Mean Systolic Blood Pressure at 12 weeks for Candesartan in NCT03640312
Change in Mean Systolic Blood Pressure at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Systolic Blood Pressure at 6 weeks (NCT03640312)
6 weeks
Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
Mean Systolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Change in Mean Diastolic Blood Pressure at 6 weeks
Change in Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
Change in Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
Change in Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
Change in Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Diastolic Blood Pressure at 6 weeks
Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Proportion of Patients With Hypertension Control at 6 and 12 weeks
Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)
6 and 12 weeks
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks at (NCT03640312)
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for QUARTET LDQT in NCT03640312
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for Candesartan in NCT03640312
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks at (NCT03640312)
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for QUARTET LDQT in NCT03640312
Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for Candesartan in NCT03640312
Outcome Analysis List for Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)
Proportion of Patients With Hypertension Control at 6 and 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Number of Patients Requiring Step up Treatment at 6 weeks
Number of Patients Requiring Step up Treatment at 6 weeks (NCT03640312)
Number of Patients Requiring Step up Treatment at 6 weeks for QUARTET LDQT in NCT03640312
Number of Patients Requiring Step up Treatment at 6 weeks for Candesartan in NCT03640312
Number of Patients Requiring Step up Treatment at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks
Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)
Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for QUARTET LDQT in NCT03640312
Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for Candesartan in NCT03640312
Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Medication Adherence at 12 weeks (NCT03640312)
Medication Adherence at 12 weeks for QUARTET LDQT in NCT03640312
Medication Adherence at 12 weeks for Candesartan in NCT03640312
Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Health-related Quality of Life at 12 weeks
Health-related Quality of Life at 12 weeks (NCT03640312)
Data are available on only 28 participants in the intervention group for the mental health T score.
Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) at (NCT03640312)
Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for QUARTET LDQT in NCT03640312
Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for Candesartan in NCT03640312
Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) at (NCT03640312)
Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for QUARTET LDQT in NCT03640312
Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312
Outcome Analysis List for Health-related Quality of Life at 12 weeks (NCT03640312)
Health-related Quality of Life at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Change in Mean Systolic Blood Pressure at 6 weeks
Change in Mean Systolic Blood Pressure at 6 weeks (NCT03640312)
Change in Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
Change in Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
Change in Mean Systolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks
Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)
All randomized participants
Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312
Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for Candesartan in NCT03640312
Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Percentage of Participants With Potentially Related Adverse Events at 12 weeks
Percentage of Participants With Potentially Related Adverse Events at 12 weeks (NCT03640312)
Percentage of Participants With Potentially Related Adverse Events at 12 weeks for QUARTET LDQT in NCT03640312
Percentage of Participants With Potentially Related Adverse Events at 12 weeks for Candesartan in NCT03640312
Percentage of Participants With Potentially Related Adverse Events at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Rate of Adverse Events of Special Interest at 12 weeks
Rate of Adverse Events of Special Interest at 12 weeks (NCT03640312)
Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312
Rate of Adverse Events of Special Interest at 12 weeks for Candesartan in NCT03640312
Rate of Adverse Events of Special Interest at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Change in Serum Potassium at 12 weeks
Mean Change in Serum Potassium at 12 weeks (NCT03640312)
Mean Change in Serum Potassium at 12 weeks for QUARTET LDQT in NCT03640312
Mean Change in Serum Potassium at 12 weeks for Candesartan in NCT03640312
Mean Change in Serum Potassium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Change in Serum Sodium at 12 weeks (NCT03640312)
Mean Change in Serum Sodium at 12 weeks for QUARTET LDQT in NCT03640312
Mean Change in Serum Sodium at 12 weeks for Candesartan in NCT03640312
Mean Change in Serum Sodium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Change in Blood Urea Nitrogen at 12 weeks
Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)
Mean Change in Blood Urea Nitrogen at 12 weeks for QUARTET LDQT in NCT03640312
Mean Change in Blood Urea Nitrogen at 12 weeks for Candesartan in NCT03640312
Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312
Mean Change in Serum Creatinine at 12 weeks
Mean Change in Serum Creatinine at 12 weeks (NCT03640312)
Mean Change in Serum Creatinine at 12 weeks for QUARTET LDQT in NCT03640312
Mean Change in Serum Creatinine at 12 weeks for Candesartan in NCT03640312
Mean Change in Serum Creatinine at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312