ID

32738

Descripción

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00660309

Link

https://clinicaltrials.gov/show/NCT00660309

Palabras clave

Versiones (1)
  1. 13/11/18 13/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00660309

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00660309

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
hypertensive, male and females of non-child bearing potential patients, with type 2 diabetes mellitus (t2dm) (diagnosed at least 8 weeks before screening), with or without renal impairment; estimated glomerular filtration rate (egfr) ≥ 40 ml/min/1.73 m^2, documented at least 3 months before the study start, aged 18-75 years with a minimum body weight of 50 kg and having an appropriate intravenous access as determined by the study staff, able to communicate well were enrolled in the study.
Descripción

Hypertensive disease | Infertility | Non-Insulin-Dependent Diabetes Mellitus Disease length | Renal Insufficiency | Renal Insufficiency Absent | Estimated Glomerular Filtration Rate | Age | Body Weight | Access Intravenous Appropriate | Able to communicate Well

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0021359
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
UMLS CUI [4]
C1565489
UMLS CUI [5,1]
C1565489
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C3811844
UMLS CUI [7]
C0001779
UMLS CUI [8]
C0005910
UMLS CUI [9,1]
C0444454
UMLS CUI [9,2]
C0348016
UMLS CUI [9,3]
C1548787
UMLS CUI [10,1]
C2364293
UMLS CUI [10,2]
C0205170
patients must be on a stable dose of hypoglycemic medications for at least 8 weeks prior to the study.
Descripción

Hypoglycemic Agents Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patients must be medically able to discontinue anti- hypertensive medications for the duration of the study.
Descripción

Ability Antihypertensive Agents Discontinue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0003364
UMLS CUI [1,3]
C1444662
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes mellitus or uncontrolled t2dm (hba1c> 11%), egfr <40 ml/min/1.73 m^2 (calculated by the modification of diet in renal disease (mdrd) formula), renal disease not caused by diabetes or hypertension, serum potassium < 3.5 or > 5.1 meq/l, heart failure (new york heart association (nyha) class ii-iv) or history of acute/decompensated heart failure within the 6 months prior to dosing, history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (pci) during the 6 months prior to the baseline visit, history of malignancy including leukemia and lymphoma within past five years, hypertensive encephalopathy any time in the past or cerebrovascular accident within the 6 months prior to the baseline visit, or with history of drug or alcohol abuse within the 12 months prior to dosing were excluded from the study.
Descripción

Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement | GFR estimation by MDRD | Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease | Serum potassium measurement | Heart failure New York Heart Association Classification | History of heart failure | Decompensated cardiac failure | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Malignant Neoplasms | Leukemia | Lymphoma | Hypertensive Encephalopathy | Cerebrovascular accident | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0743118
UMLS CUI [3]
C0474680
UMLS CUI [4]
C2170215
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0332291
UMLS CUI [5,3]
C0011849
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0332291
UMLS CUI [6,3]
C0020538
UMLS CUI [7]
C0302353
UMLS CUI [8,1]
C0018801
UMLS CUI [8,2]
C1275491
UMLS CUI [9]
C0455531
UMLS CUI [10]
C0581377
UMLS CUI [11]
C0027051
UMLS CUI [12]
C0002965
UMLS CUI [13]
C0010055
UMLS CUI [14]
C1532338
UMLS CUI [15]
C0006826
UMLS CUI [16]
C0023418
UMLS CUI [17]
C0024299
UMLS CUI [18]
C0151620
UMLS CUI [19]
C0038454
UMLS CUI [20]
C0038586
patients with glaucoma, or prior ocular surgery.
Descripción

Glaucoma | Ophthalmologic Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017601
UMLS CUI [2]
C0038901
patients with renal disease not caused by diabetes or hypertension.
Descripción

Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0020538
patients with history of clinically significant drug or atopic allergy, acute or chronic respiratory disease, history of malignancy, or history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any coronary intervention (percutaneous coronary intervention; pci) during the 6 months prior to the study.
Descripción

Drug Allergy | Atopy | Respiration Disorders | Chronic disease of respiratory system | Malignant Neoplasms | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0392707
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0264220
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0027051
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0010055
UMLS CUI [9]
C1532338
patients who had used any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics within 2 weeks prior to dosing and during the study, over-the-counter (otc) medication within two (2) weeks prior to dosing,
Descripción

Pharmaceutical Preparations Affecting Renin-Angiotensin-Aldosterone System | Pharmaceutical Preparations Effect Hemodynamics renal | Drugs, Non-Prescription

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0086907
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0019010
UMLS CUI [2,4]
C0022646
UMLS CUI [3]
C0013231
any surgical or medical condition which may jeopardize the patient in case of participation in the study.
Descripción

Condition Surgical compromises Study Subject Participation Status | Medical condition compromises Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
participation in any clinical investigation within 4 weeks prior to the study.
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
donation or loss of 400 ml or more of blood within 8 weeks prior to the study.
Descripción

Blood Donation Amount | Blood Loss Amount

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
other protocol-defined inclusion/exclusion criteria may apply.
Descripción

Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00660309

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Infertility | Non-Insulin-Dependent Diabetes Mellitus Disease length | Renal Insufficiency | Renal Insufficiency Absent | Estimated Glomerular Filtration Rate | Age | Body Weight | Access Intravenous Appropriate | Able to communicate Well
Item
hypertensive, male and females of non-child bearing potential patients, with type 2 diabetes mellitus (t2dm) (diagnosed at least 8 weeks before screening), with or without renal impairment; estimated glomerular filtration rate (egfr) ≥ 40 ml/min/1.73 m^2, documented at least 3 months before the study start, aged 18-75 years with a minimum body weight of 50 kg and having an appropriate intravenous access as determined by the study staff, able to communicate well were enrolled in the study.
boolean
C0020538 (UMLS CUI [1])
C0021359 (UMLS CUI [2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C1565489 (UMLS CUI [4])
C1565489 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3811844 (UMLS CUI [6])
C0001779 (UMLS CUI [7])
C0005910 (UMLS CUI [8])
C0444454 (UMLS CUI [9,1])
C0348016 (UMLS CUI [9,2])
C1548787 (UMLS CUI [9,3])
C2364293 (UMLS CUI [10,1])
C0205170 (UMLS CUI [10,2])
Hypoglycemic Agents Dose Stable
Item
patients must be on a stable dose of hypoglycemic medications for at least 8 weeks prior to the study.
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Ability Antihypertensive Agents Discontinue
Item
patients must be medically able to discontinue anti- hypertensive medications for the duration of the study.
boolean
C0085732 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement | GFR estimation by MDRD | Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease | Serum potassium measurement | Heart failure New York Heart Association Classification | History of heart failure | Decompensated cardiac failure | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Malignant Neoplasms | Leukemia | Lymphoma | Hypertensive Encephalopathy | Cerebrovascular accident | Substance Use Disorders
Item
patients with type 1 diabetes mellitus or uncontrolled t2dm (hba1c> 11%), egfr <40 ml/min/1.73 m^2 (calculated by the modification of diet in renal disease (mdrd) formula), renal disease not caused by diabetes or hypertension, serum potassium < 3.5 or > 5.1 meq/l, heart failure (new york heart association (nyha) class ii-iv) or history of acute/decompensated heart failure within the 6 months prior to dosing, history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (pci) during the 6 months prior to the baseline visit, history of malignancy including leukemia and lymphoma within past five years, hypertensive encephalopathy any time in the past or cerebrovascular accident within the 6 months prior to the baseline visit, or with history of drug or alcohol abuse within the 12 months prior to dosing were excluded from the study.
boolean
C0011854 (UMLS CUI [1])
C0743118 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C2170215 (UMLS CUI [4])
C0022658 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C0011849 (UMLS CUI [5,3])
C0022658 (UMLS CUI [6,1])
C0332291 (UMLS CUI [6,2])
C0020538 (UMLS CUI [6,3])
C0302353 (UMLS CUI [7])
C0018801 (UMLS CUI [8,1])
C1275491 (UMLS CUI [8,2])
C0455531 (UMLS CUI [9])
C0581377 (UMLS CUI [10])
C0027051 (UMLS CUI [11])
C0002965 (UMLS CUI [12])
C0010055 (UMLS CUI [13])
C1532338 (UMLS CUI [14])
C0006826 (UMLS CUI [15])
C0023418 (UMLS CUI [16])
C0024299 (UMLS CUI [17])
C0151620 (UMLS CUI [18])
C0038454 (UMLS CUI [19])
C0038586 (UMLS CUI [20])
Glaucoma | Ophthalmologic Surgical Procedures
Item
patients with glaucoma, or prior ocular surgery.
boolean
C0017601 (UMLS CUI [1])
C0038901 (UMLS CUI [2])
Kidney Disease Independent of Diabetes Mellitus | Kidney Disease Independent of Hypertensive disease
Item
patients with renal disease not caused by diabetes or hypertension.
boolean
C0022658 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0020538 (UMLS CUI [2,3])
Drug Allergy | Atopy | Respiration Disorders | Chronic disease of respiratory system | Malignant Neoplasms | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
patients with history of clinically significant drug or atopic allergy, acute or chronic respiratory disease, history of malignancy, or history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any coronary intervention (percutaneous coronary intervention; pci) during the 6 months prior to the study.
boolean
C0013182 (UMLS CUI [1])
C0392707 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0264220 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0010055 (UMLS CUI [8])
C1532338 (UMLS CUI [9])
Pharmaceutical Preparations Affecting Renin-Angiotensin-Aldosterone System | Pharmaceutical Preparations Effect Hemodynamics renal | Drugs, Non-Prescription
Item
patients who had used any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics within 2 weeks prior to dosing and during the study, over-the-counter (otc) medication within two (2) weeks prior to dosing,
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0086907 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0019010 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C0013231 (UMLS CUI [3])
Condition Surgical compromises Study Subject Participation Status | Medical condition compromises Study Subject Participation Status
Item
any surgical or medical condition which may jeopardize the patient in case of participation in the study.
boolean
C0348080 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Study Subject Participation Status
Item
participation in any clinical investigation within 4 weeks prior to the study.
boolean
C2348568 (UMLS CUI [1])
Blood Donation Amount | Blood Loss Amount
Item
donation or loss of 400 ml or more of blood within 8 weeks prior to the study.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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