ID

39998

Beschreibung

INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria; ODM derived from: https://clinicaltrials.gov/show/NCT01398423

Link

https://clinicaltrials.gov/show/NCT01398423

Stichworte

Versionen (1)
  1. 09.03.20 09.03.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. März 2020

DOI

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Eligibility Hypertension NCT01398423

Englisch

Eligibility Hypertension NCT01398423

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women, 18 to 85 years of age, inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. able and willing to understand and provide written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. documented hypertension defined by 1 of the following:
Beschreibung

Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
currently treated with antihypertensive medications, or untreated with a seated systolic blood pressure (mean of 3 readings) between 126 and 180 millimeters of mercury (mm hg).
Beschreibung

Antihypertensive Agents | Patients Untreated | Sitting systolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
4. documented type 2 diabetes mellitus defined by 1 of the following:
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
currently treated with anti-diabetic medication (oral and/or insulin), or fasting serum glucose level ≥126 mg/dl.
Beschreibung

Antidiabetics Oral | Insulin | Glucose measurement, fasting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0202045
5. documented nephropathy evidenced by a uacr of 300 to 3000 mg/g.
Beschreibung

Kidney Disease | Urine albumin/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0455271
6. both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use 1 of the following forms of reliable contraception:
Beschreibung

Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Female Sterilization Absent | Postmenopausal state Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
abstinence, meaning a total lack of sexual activity, oral contraceptives ("the pill") or other hormonal contraceptive methods, intrauterine device, double-barrier method (diaphragm or condom plus spermicidal cream), or if female, male partner sterilization.
Beschreibung

Sexual Abstinence | Contraceptives, Oral | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Vaginal contraceptive diaphragm | Female Condoms | Spermicidal Cream | Partner had vasectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0036899
UMLS CUI [2]
C0009905
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0221829
UMLS CUI [8]
C2985328
UMLS CUI [9]
C0420842
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. required use of an ace inhibitor, arb, direct renin inhibitor, or aldosterone antagonist other than study drug, while on the study.
Beschreibung

Angiotensin-Converting Enzyme Inhibitor Required | Angiotensin II receptor antagonist Required | DIRECT RENIN INHIBITOR Required | Aldosterone Antagonist Required | Exception Investigational New Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C1950687
UMLS CUI [3,2]
C1514873
UMLS CUI [4,1]
C0002007
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0013230
2. systolic blood pressure >180 mm hg (mean of 3 seated readings, 5 minutes apart, using the subject's dominant arm).
Beschreibung

Sitting systolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
3. chronic kidney disease stage 4 or higher defined as an estimated glomerular filtration rate <30 ml/min per 1.73 m2 (abbreviated mdrd equation).
Beschreibung

Chronic Kidney Disease Stage | GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C2170215
4. hepatic impairment defined by serum alanine aminotransferase (alt) or aspartate aminotransferase (ast)>2 x the upper limit of normal.
Beschreibung

Hepatic impairment | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
5. diagnosis of type 1 diabetes or non-diabetic renal disease, including but not limited to renal-artery stenosis, primary glomerular disease, autoimmune renal diseases, etc.
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Kidney Disease | Diabetic Nephropathy Absent | Renal Artery Stenosis | Glomerular disease Primary | Autoimmune Disease renal

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0022658
UMLS CUI [3,1]
C0011881
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0035067
UMLS CUI [5,1]
C0268731
UMLS CUI [5,2]
C0205225
UMLS CUI [6,1]
C0004364
UMLS CUI [6,2]
C0022646
6. severe anemia defined as hemoglobin < 8 g/dl.
Beschreibung

Anemia, severe | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518015
7. congestive heart failure with new york heart association class ii, iii, or iv symptoms.
Beschreibung

Congestive heart failure Symptoms New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
8. thiamine (vitamin b1) deficiency or known alcohol abuse within the past year. if alcohol abuse is suspected, subject must have a normal thiamine blood level documented prior to study entry.
Beschreibung

Thiamine Deficiency | Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0039841
UMLS CUI [2]
C0085762
9. any radiocontrast-facilitated study within 30 days prior to study day 1.
Beschreibung

Contrast radiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0542435
10. cerebrovascular accident within the previous 6 months, or have had a transient ischemic attack within the previous year.
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
11. pregnant or nursing women; women of childbearing potential must have a negative serum pregnancy test at screen.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
12. known adverse reaction to losartan and/or ala.
Beschreibung

Adverse reaction caused by losartan | Adverse reaction Alpha Lipoic Acid

Datentyp

boolean

Alias
UMLS CUI [1]
C0570459
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0023791
13. participation in another clinical trial or have received an investigational agent for any reason within 30 days of study day 1.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
14. any other condition that in the opinion of the investigator, may adversely affect the safety of the subject, the subject's ability to complete the study, or the outcome of the study.
Beschreibung

Condition Interferes with Patient safety | Condition Interferes with Completion of clinical trial | Condition Interferes with Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
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Ähnliche Modelle

Eligibility Hypertension NCT01398423

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men or women, 18 to 85 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. able and willing to understand and provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Hypertensive disease
Item
3. documented hypertension defined by 1 of the following:
boolean
C0020538 (UMLS CUI [1])
Antihypertensive Agents | Patients Untreated | Sitting systolic blood pressure mean
Item
currently treated with antihypertensive medications, or untreated with a seated systolic blood pressure (mean of 3 readings) between 126 and 180 millimeters of mercury (mm hg).
boolean
C0003364 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
4. documented type 2 diabetes mellitus defined by 1 of the following:
boolean
C0011860 (UMLS CUI [1])
Antidiabetics Oral | Insulin | Glucose measurement, fasting
Item
currently treated with anti-diabetic medication (oral and/or insulin), or fasting serum glucose level ≥126 mg/dl.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
C0202045 (UMLS CUI [3])
Kidney Disease | Urine albumin/creatinine ratio measurement
Item
5. documented nephropathy evidenced by a uacr of 300 to 3000 mg/g.
boolean
C0022658 (UMLS CUI [1])
C0455271 (UMLS CUI [2])
Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Female Sterilization Absent | Postmenopausal state Absent
Item
6. both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use 1 of the following forms of reliable contraception:
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Sexual Abstinence | Contraceptives, Oral | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Vaginal contraceptive diaphragm | Female Condoms | Spermicidal Cream | Partner had vasectomy
Item
abstinence, meaning a total lack of sexual activity, oral contraceptives ("the pill") or other hormonal contraceptive methods, intrauterine device, double-barrier method (diaphragm or condom plus spermicidal cream), or if female, male partner sterilization.
boolean
C0036899 (UMLS CUI [1])
C0009905 (UMLS CUI [2])
C2985296 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0042241 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C2985328 (UMLS CUI [8])
C0420842 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Angiotensin-Converting Enzyme Inhibitor Required | Angiotensin II receptor antagonist Required | DIRECT RENIN INHIBITOR Required | Aldosterone Antagonist Required | Exception Investigational New Drug
Item
1. required use of an ace inhibitor, arb, direct renin inhibitor, or aldosterone antagonist other than study drug, while on the study.
boolean
C0003015 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521942 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1950687 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0002007 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
Sitting systolic blood pressure mean
Item
2. systolic blood pressure >180 mm hg (mean of 3 seated readings, 5 minutes apart, using the subject's dominant arm).
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Chronic Kidney Disease Stage | GFR estimation by MDRD
Item
3. chronic kidney disease stage 4 or higher defined as an estimated glomerular filtration rate <30 ml/min per 1.73 m2 (abbreviated mdrd equation).
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Hepatic impairment | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
4. hepatic impairment defined by serum alanine aminotransferase (alt) or aspartate aminotransferase (ast)>2 x the upper limit of normal.
boolean
C0948807 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Kidney Disease | Diabetic Nephropathy Absent | Renal Artery Stenosis | Glomerular disease Primary | Autoimmune Disease renal
Item
5. diagnosis of type 1 diabetes or non-diabetic renal disease, including but not limited to renal-artery stenosis, primary glomerular disease, autoimmune renal diseases, etc.
boolean
C0011854 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0011881 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0035067 (UMLS CUI [4])
C0268731 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0004364 (UMLS CUI [6,1])
C0022646 (UMLS CUI [6,2])
Anemia, severe | Hemoglobin measurement
Item
6. severe anemia defined as hemoglobin < 8 g/dl.
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Congestive heart failure Symptoms New York Heart Association Classification
Item
7. congestive heart failure with new york heart association class ii, iii, or iv symptoms.
boolean
C0018802 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Thiamine Deficiency | Alcohol abuse
Item
8. thiamine (vitamin b1) deficiency or known alcohol abuse within the past year. if alcohol abuse is suspected, subject must have a normal thiamine blood level documented prior to study entry.
boolean
C0039841 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Contrast radiography
Item
9. any radiocontrast-facilitated study within 30 days prior to study day 1.
boolean
C0542435 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
10. cerebrovascular accident within the previous 6 months, or have had a transient ischemic attack within the previous year.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative
Item
11. pregnant or nursing women; women of childbearing potential must have a negative serum pregnancy test at screen.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Adverse reaction caused by losartan | Adverse reaction Alpha Lipoic Acid
Item
12. known adverse reaction to losartan and/or ala.
boolean
C0570459 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0023791 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
13. participation in another clinical trial or have received an investigational agent for any reason within 30 days of study day 1.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Interferes with Patient safety | Condition Interferes with Completion of clinical trial | Condition Interferes with Research results
Item
14. any other condition that in the opinion of the investigator, may adversely affect the safety of the subject, the subject's ability to complete the study, or the outcome of the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
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