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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754HFA3002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin 100 mg | Experimental | Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will be administered matching placebo capsules orally once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin 100 mg | Drug | Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 | Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily Step Count at Week 12 | Change from baseline in total daily step count at Week 12 was reported in this outcome measure. The number of steps taken per day was measured using a step activity monitor at baseline and throughout the study. Step count was measured from the Fitbit device data. The Fitbit app on the participant's phone collected all data from the Fitbit device. A negative change from baseline indicated a decrease in the number of daily steps. |
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Inclusion Criteria:
- Have clinically stable symptomatic heart failure (HF) (heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]): (A) For HFrEF: (a) ejection fraction (EF) less than or equal to (<=) 40 percent (%) and (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or eplerenone (mineralocorticoid receptor antagonists), in the past 18 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Clinic Cardiology - Fort Smith | Fort Smith | Arkansas | 72903 | United States | ||
| University of Colorado Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38385941 | Derived | Mohebi R, Jones PG, Spertus JA, Lingvay I, Lanfear DE, Gosch KL, Birmingham M, Kosiborod MN, Butler J, Januzzi JL Jr. Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin. JACC Heart Fail. 2024 Apr;12(4):711-718. doi: 10.1016/j.jchf.2024.01.005. Epub 2024 Feb 21. | |
| 37498273 | Derived |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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A total of 1,333 participants were screened. Of which, 476 participants were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks. |
| FG001 | Canagliflozin 100 mg | Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2021 | Dec 20, 2022 |
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| Placebo | Drug | Participants will receive matching placebo capsules orally once daily. |
|
| Baseline, Week 12 |
| Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12 | Change from baseline in KCCQ physical limitation score and KCCQ quality of life score were reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status. | Baseline, Week 12 |
| Change From Baseline in KCCQ Clinical Summary Score at Week 12 | Change from baseline in KCCQ-clinical summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. | Baseline, Week 12 |
| Change From Baseline in KCCQ Overall Summary Score at Week 12 | Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. | Baseline, Week 12 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Emory University | Atlanta | Georgia | 30022 | United States |
| St Lukes Regional Medical | Boise | Idaho | 83712 | United States |
| OSF HealthCare Cardiovascular Institute | Peoria | Illinois | 61614 | United States |
| Central Dupage Hospital | Winfield | Illinois | 60190 | United States |
| Parkview Cancer Institute | Fort Wayne | Indiana | 46845 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| St. Luke's Hospital Kansas City | Kansas City | Missouri | 64111 | United States |
| Mercy Health Research | Washington | Missouri | 63090 | United States |
| Robert Wood Johnson Medical School Dept. of Medicine | Piscataway | New Jersey | 08854 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Thomas Spann Clinic | Corpus Christi | Texas | 78412 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| Golbus JR, Gosch K, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Damaraju CV, Januzzi JL Jr, Spertus J, Nallamothu BK. Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure. JACC Heart Fail. 2023 Nov;11(11):1521-1530. doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26. |
| 37040839 | Derived | Nassif M, Birmingham MC, Lanfear DE, Golbus JR, Gupta B, Fawcett C, Harrison MC, Spertus JA. Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial. J Card Fail. 2023 Jun;29(6):863-869. doi: 10.1016/j.cardfail.2023.04.001. Epub 2023 Apr 10. |
| 35228753 | Derived | Spertus JA, Birmingham MC, Nassif M, Damaraju CV, Abbate A, Butler J, Lanfear DE, Lingvay I, Kosiborod MN, Januzzi JL. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022 Apr;28(4):809-813. doi: 10.1038/s41591-022-01703-8. Epub 2022 Feb 28. |
| 33724883 | Derived | Spertus JA, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Fawcett C, Burton P, Damaraju CV, Januzzi JL, Whang J. Novel Trial Design: CHIEF-HF. Circ Heart Fail. 2021 Mar;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767. Epub 2021 Mar 16. |
| Treated (Safety Analysis Set) | Safety analysis set included all randomized participants who received at least 1 dose of study intervention. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks. |
| BG001 | Canagliflozin 100 mg | Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 | Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. | Full analysis set (FAS) included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Total Daily Step Count at Week 12 | Change from baseline in total daily step count at Week 12 was reported in this outcome measure. The number of steps taken per day was measured using a step activity monitor at baseline and throughout the study. Step count was measured from the Fitbit device data. The Fitbit app on the participant's phone collected all data from the Fitbit device. A negative change from baseline indicated a decrease in the number of daily steps. | FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | Least Squares Mean | Standard Error | Daily step count | Baseline, Week 12 |
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| Secondary | Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12 | Change from baseline in KCCQ physical limitation score and KCCQ quality of life score were reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status. | FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants with available data for each specified category. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in KCCQ Clinical Summary Score at Week 12 | Change from baseline in KCCQ-clinical summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. | FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in KCCQ Overall Summary Score at Week 12 | Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. | FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 12 |
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All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks. | 5 | 231 | 36 | 231 | 0 | 231 |
| EG001 | Canagliflozin 100 mg | Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks. | 3 | 224 | 33 | 224 | 0 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Ulcer haemorrhage | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Heart rate increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Bell's palsy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cardiac operation | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
Not provided
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director CVM Health Equity | Janssen Scientific Affairs, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2021 | Dec 20, 2022 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
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| Black or African American |
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| Asian |
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| Other |
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| Participants |
|
|
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Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
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Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks. |
|
|
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks. |
|
|