ID

40080

Description

8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01570686

Link

https://clinicaltrials.gov/show/NCT01570686

Keywords

Versions (1)
  1. 3/11/20 3/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01570686

English

Eligibility Hypertension NCT01570686

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
Description

Essential Hypertension Untreated | Essential Hypertension | Antihypertensive therapy | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0085580
UMLS CUI [3]
C0585941
UMLS CUI [4]
C0009429
patients with an office bp ≥ 140/90 mmhg and < 180/110mmhg at the randomization visit and the preceding visit
Description

Blood pressure determination | Randomization Visit | Visit preceding

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C1512346
UMLS CUI [3,1]
C1512346
UMLS CUI [3,2]
C0332152
patients must have an absolute difference of ≤ 10 mmhg in both their mssbp and their msdbp between the randomization visit and the preceding visit
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Difference Absolute | Randomization Visit | Visit preceding

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1705242
UMLS CUI [3,2]
C0205344
UMLS CUI [4,1]
C0034656
UMLS CUI [4,2]
C1512346
UMLS CUI [5,1]
C1512346
UMLS CUI [5,2]
C0332152
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
malignant hypertension or severe hypertension (grade 3 of who classification; mssbp
Description

Malignant Hypertension | Severe Hypertension Grade WHO classification | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0020540
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C4267671
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
≥180 mmhg or msdbp ≥110 mmhg)
Description

Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
history or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (pkd).
Description

Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Aortic coarctation | Conn Syndrome | Cushing's disease | Hypertension secondary to drug | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Pheochromocytoma | Polycystic Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0264649
UMLS CUI [3]
C0020545
UMLS CUI [4]
C0003492
UMLS CUI [5]
C1384514
UMLS CUI [6]
C0221406
UMLS CUI [7]
C0581373
UMLS CUI [8]
C0856759
UMLS CUI [9]
C0856760
UMLS CUI [10]
C0031511
UMLS CUI [11]
C0022680
type 1 or type 2 diabetes mellitus with a fasting glycosylated hemoglobin (hba1c) > 8%
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0474680
UMLS CUI [3,2]
C0015663
evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x uln or egfr < 30 ml/min/1.73m2 at visit 1, a history of dialysis, or a history of nephrotic syndrome
Description

Renal Insufficiency | Serum creatinine raised | Estimated Glomerular Filtration Rate | Dialysis | Nephrotic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C3811844
UMLS CUI [4]
C0011946
UMLS CUI [5]
C0027726
other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Hypertension NCT01570686

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Untreated | Essential Hypertension | Antihypertensive therapy | Combined Modality Therapy
Item
patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
boolean
C0085580 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Blood pressure determination | Randomization Visit | Visit preceding
Item
patients with an office bp ≥ 140/90 mmhg and < 180/110mmhg at the randomization visit and the preceding visit
boolean
C0005824 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C1512346 (UMLS CUI [2,2])
C1512346 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Difference Absolute | Randomization Visit | Visit preceding
Item
patients must have an absolute difference of ≤ 10 mmhg in both their mssbp and their msdbp between the randomization visit and the preceding visit
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1705242 (UMLS CUI [3,1])
C0205344 (UMLS CUI [3,2])
C0034656 (UMLS CUI [4,1])
C1512346 (UMLS CUI [4,2])
C1512346 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Malignant Hypertension | Severe Hypertension Grade WHO classification | Sitting systolic blood pressure mean
Item
malignant hypertension or severe hypertension (grade 3 of who classification; mssbp
boolean
C0020540 (UMLS CUI [1])
C4013784 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C4267671 (UMLS CUI [2,3])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Sitting diastolic blood pressure mean
Item
≥180 mmhg or msdbp ≥110 mmhg)
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Aortic coarctation | Conn Syndrome | Cushing's disease | Hypertension secondary to drug | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Pheochromocytoma | Polycystic Kidney Diseases
Item
history or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (pkd).
boolean
C0155616 (UMLS CUI [1])
C0264649 (UMLS CUI [2])
C0020545 (UMLS CUI [3])
C0003492 (UMLS CUI [4])
C1384514 (UMLS CUI [5])
C0221406 (UMLS CUI [6])
C0581373 (UMLS CUI [7])
C0856759 (UMLS CUI [8])
C0856760 (UMLS CUI [9])
C0031511 (UMLS CUI [10])
C0022680 (UMLS CUI [11])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement Fasting
Item
type 1 or type 2 diabetes mellitus with a fasting glycosylated hemoglobin (hba1c) > 8%
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0474680 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
Renal Insufficiency | Serum creatinine raised | Estimated Glomerular Filtration Rate | Dialysis | Nephrotic Syndrome
Item
evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x uln or egfr < 30 ml/min/1.73m2 at visit 1, a history of dialysis, or a history of nephrotic syndrome
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
C0011946 (UMLS CUI [4])
C0027726 (UMLS CUI [5])
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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