ID

38827

Descripción

24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02182830

Link

https://clinicaltrials.gov/show/NCT02182830

Palabras clave

Versiones (1)
  1. 7/11/19 7/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02182830

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT02182830

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of type 2 diabetes mellitus (t2dm)
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
2. male and female black/african american patients on diet and exercise regimen who are drug-naïve or pre-treated with stable dose of metformin.
Descripción

Gender | African American | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Pretreatment Metformin Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0085756
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C3539076
UMLS CUI [6,2]
C0025598
UMLS CUI [6,3]
C0178602
UMLS CUI [6,4]
C0205360
3. hba1c of greater than and equal to 7.5% (58 mmol/mol) and less than and equal to 11.0% (97 mmol/mol) at screening
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
4. mean seated systolic blood (sbp) 140-180 mmhg and diastolic blood pressure (dbp) 90-110 mmhg at screening
Descripción

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
5. successful completion of baseline ambulatory blood pressure measurement (abpm) with a mean sbp 135-175 mmhg prior to randomization.
Descripción

Ambulatory Blood Pressure Monitoring Completion | Systolic Pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0444504
6. treatment with stable doses of less than and equal to 3 antihypertensive medication greater than and equal to 4 weeks prior to randomization.
Descripción

Antihypertensive Agents Quantity Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
7. age greater than and equal to18 years at screening
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
8. signed and dated written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Descripción

Hyperglycemia Uncontrolled | Glucose level | Status post Fasting Overnight

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0428548
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0015663
UMLS CUI [3,3]
C0439583
2. any other antidiabetic medication other than metformin.
Descripción

Antidiabetics | Exception Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
3. hypertension treatment with minoxidil.
Descripción

Hypertension treatment | Minoxidil

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0578998
UMLS CUI [2]
C0026196
4. mean seated sbp >=181 mmhg and/or mean seated dbp>=111 mmhg during placebo run-in visit and confirmed by a second measurement.
Descripción

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
5. diagnosis of autoimmune diabetes/type i diabetes mellitus, monogenic (neonatal or mody) diabetes or type i diabetes in adults/ latent autoimmune diabetes of adults (lada) per investigator or patient medical history at the time of screening.
Descripción

Diabetes, Autoimmune | Diabetes Mellitus, Insulin-Dependent | Monogenic diabetes | Neonatal diabetes mellitus | Maturity onset diabetes mellitus in young | Insulin-Dependent Diabetes Mellitus Adult | Latent Autoimmune Diabetes in Adults

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205734
UMLS CUI [2]
C0011854
UMLS CUI [3]
C3888631
UMLS CUI [4]
C0158981
UMLS CUI [5]
C0342276
UMLS CUI [6,1]
C0011854
UMLS CUI [6,2]
C0001675
UMLS CUI [7]
C1739108
6. known or suspected secondary hypertension (e.g. renal artery stenosis, phaeochromocytoma).
Descripción

Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0035067
UMLS CUI [4]
C0031511
7. history or evidence of hypertensive retinopathy (keith-wagener grade iii or iv) and/or hypertensive encephalopathy.
Descripción

Hypertensive Retinopathy Grade | Hypertensive Encephalopathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C0151620
8. impaired renal function, defined as estimated glomerular filtration rate (egfr)< 45 ml/min/1.73m2 (moderate renal impairment,chronic kidney disease epidemiology collaboration (ckd-epi) formula) as determined during screening and/or run-in phase.
Descripción

Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate | Creatinine-based formula (CKD-EPI)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205081
UMLS CUI [4]
C2964649
9. medical history and signs and symptoms of diabetic autonomic neuropathy.
Descripción

Diabetic Autonomic Neuropathy | Signs and Symptoms Diabetic Autonomic Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0271686
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0271686
10. systolic blood pressure difference of >10 mmhg between the arms at screening.
Descripción

Systolic Pressure Difference Arm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C1522541
11. pre-menopausal women who:
Descripción

Premenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232969
are nursing or pregnant or
Descripción

Breast Feeding | Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Descripción

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0332182
UMLS CUI [2,4]
C0558080
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02182830

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Gender | African American | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Pretreatment Metformin Dose Stable
Item
2. male and female black/african american patients on diet and exercise regimen who are drug-naïve or pre-treated with stable dose of metformin.
boolean
C0079399 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3539076 (UMLS CUI [6,1])
C0025598 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
Hemoglobin A1c measurement
Item
3. hba1c of greater than and equal to 7.5% (58 mmol/mol) and less than and equal to 11.0% (97 mmol/mol) at screening
boolean
C0474680 (UMLS CUI [1])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean seated systolic blood (sbp) 140-180 mmhg and diastolic blood pressure (dbp) 90-110 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Ambulatory Blood Pressure Monitoring Completion | Systolic Pressure mean
Item
5. successful completion of baseline ambulatory blood pressure measurement (abpm) with a mean sbp 135-175 mmhg prior to randomization.
boolean
C0242876 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Quantity Dose Stable
Item
6. treatment with stable doses of less than and equal to 3 antihypertensive medication greater than and equal to 4 weeks prior to randomization.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Age
Item
7. age greater than and equal to18 years at screening
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
8. signed and dated written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level | Status post Fasting Overnight
Item
1. uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
C0439583 (UMLS CUI [3,3])
Antidiabetics | Exception Metformin
Item
2. any other antidiabetic medication other than metformin.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Hypertension treatment | Minoxidil
Item
3. hypertension treatment with minoxidil.
boolean
C0578998 (UMLS CUI [1])
C0026196 (UMLS CUI [2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean seated sbp >=181 mmhg and/or mean seated dbp>=111 mmhg during placebo run-in visit and confirmed by a second measurement.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Diabetes, Autoimmune | Diabetes Mellitus, Insulin-Dependent | Monogenic diabetes | Neonatal diabetes mellitus | Maturity onset diabetes mellitus in young | Insulin-Dependent Diabetes Mellitus Adult | Latent Autoimmune Diabetes in Adults
Item
5. diagnosis of autoimmune diabetes/type i diabetes mellitus, monogenic (neonatal or mody) diabetes or type i diabetes in adults/ latent autoimmune diabetes of adults (lada) per investigator or patient medical history at the time of screening.
boolean
C0205734 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C3888631 (UMLS CUI [3])
C0158981 (UMLS CUI [4])
C0342276 (UMLS CUI [5])
C0011854 (UMLS CUI [6,1])
C0001675 (UMLS CUI [6,2])
C1739108 (UMLS CUI [7])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
6. known or suspected secondary hypertension (e.g. renal artery stenosis, phaeochromocytoma).
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Hypertensive Retinopathy Grade | Hypertensive Encephalopathy
Item
7. history or evidence of hypertensive retinopathy (keith-wagener grade iii or iv) and/or hypertensive encephalopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0151620 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate | Creatinine-based formula (CKD-EPI)
Item
8. impaired renal function, defined as estimated glomerular filtration rate (egfr)< 45 ml/min/1.73m2 (moderate renal impairment,chronic kidney disease epidemiology collaboration (ckd-epi) formula) as determined during screening and/or run-in phase.
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C2964649 (UMLS CUI [4])
Diabetic Autonomic Neuropathy | Signs and Symptoms Diabetic Autonomic Neuropathy
Item
9. medical history and signs and symptoms of diabetic autonomic neuropathy.
boolean
C0271686 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0271686 (UMLS CUI [2,2])
Systolic Pressure Difference Arm
Item
10. systolic blood pressure difference of >10 mmhg between the arms at screening.
boolean
C0871470 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Premenopausal state
Item
11. pre-menopausal women who:
boolean
C0232969 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
are nursing or pregnant or
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Unwilling
Item
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0332182 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
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