{ "resourceType" : "Evidence", "id" : "367941", "meta" : { "versionId" : "26", "lastUpdated" : "2025-08-18T13:22:42.074Z", "profile" : ["http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"] }, "language" : "en", "text" : { "status" : "extensions", "div" : "

Generated Narrative: Evidence 367941

version: 26; Last updated: 2025-08-18 13:22:42+0000; Language: en

Profile: ComparativeEvidence

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Evidence/367941

identifier: FEvIR Object Identifier/367941, FEvIR Linking Identifier/NCT03640312-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001

name: NCT03640312_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001

title: Change in Mean Systolic Blood Pressure at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

citeAs:

Change in Mean Systolic Blood Pressure at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367941. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367941. Computable resource at: https://fevir.net/resources/Evidence/367941#json.

\n

status: Active

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

\n

description:

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

\n

variableDefinition

note:

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.

\n

variableRole: Population

intended: Group NCT03640312 Eligibility Criteria

variableDefinition

description:

Group Assignment: QUARTET LDQT vs. Candesartan

\n

variableRole: Exposure

comparatorCategory: Candesartan

observed: Group Assignment: 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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

variableDefinition

variableRole: Outcome

observed: Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)

statistic

note: ,

Outcome Analysis NonInferiority Type: Superiority

\n

Outcome Analysis Statistical Comment: Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.

\n

statisticType: Mean Difference (Net)

quantity: -4.78 mm Hg

attributeEstimate

type: standard error of the mean

quantity: 2.97 mm Hg

attributeEstimate

note:

Adjusting for baseline systolic blood pressure.

\n

type: P-value

quantity: 0.114

attributeEstimate

note:

CI Number of Sides: 2-Sided

\n

type: Confidence interval

level: 0.95

range: -10.74-1.18 mm Hg

ModelCharacteristics

-Code
*Mixed Models Analysis
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Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367941. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367941. Computable resource at: https://fevir.net/resources/Evidence/367941#json.", "status" : "active", "author" : [{ "name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" }], "publisher" : "Computable Publishing LLC", "contact" : [{ "telecom" : [{ "system" : "email", "value" : "support@computablepublishing.com" }] }], "copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/", "description" : "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.", "variableDefinition" : [{ "note" : [{ "text" : "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." }], "variableRole" : "population", "intended" : { "reference" : "Group/367881", "type" : "Group", "identifier" : { "type" : { "text" : "FEvIR Linking Identifier" }, "system" : "https://fevir.net/FLI", "value" : "NCT03640312 Eligibility Criteria", "assigner" : { "display" : "Computable Publishing LLC" } } } }, { "description" : "Group Assignment: QUARTET LDQT vs. Candesartan", "variableRole" : "exposure", "comparatorCategory" : "Candesartan", "observed" : { "display" : "Group Assignment: 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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks." } }, { "variableRole" : "outcome", "observed" : { "reference" : "EvidenceVariable/367882", "type" : "EvidenceVariable", "identifier" : { "type" : { "text" : "FEvIR Linking Identifier" }, "system" : "https://fevir.net/FLI", "value" : "NCT03640312-primaryOutcome-0", "assigner" : { "display" : "Computable Publishing LLC" } }, "display" : "Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)" } }], "statistic" : [{ "note" : [{ "text" : "Outcome Analysis NonInferiority Type: Superiority" }, { "text" : "Outcome Analysis Statistical Comment: Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects." }], "statisticType" : { "text" : "Mean Difference (Net)" }, "quantity" : { "value" : -4.78, "unit" : "mm Hg" }, "attributeEstimate" : [{ "type" : { "coding" : [{ "system" : "https://fevir.net/sevco", "code" : "STATO:0000037", "display" : "standard error of the mean" }] }, "quantity" : { "value" : 2.97, "unit" : "mm Hg" } }, { "note" : [{ "text" : "Adjusting for baseline systolic blood pressure." }], "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type", "code" : "C44185", "display" : "P-value" }] }, "quantity" : { "value" : 0.114 } }, { "note" : [{ "text" : "CI Number of Sides: 2-Sided" }], "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type", "code" : "C53324", "display" : "Confidence interval" }] }, "level" : 0.95, "range" : { "low" : { "value" : -10.74, "unit" : "mm Hg" }, "high" : { "value" : 1.18, "unit" : "mm Hg" } } }], "modelCharacteristic" : [{ "code" : { "text" : "Mixed Models Analysis" } }] }] }