ID

39267

Description

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01599104

Link

https://clinicaltrials.gov/show/NCT01599104

Keywords

Versions (1)
  1. 12/14/19 12/14/19 -
Copyright Holder

See clinicaltrials.gov

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December 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01599104

English

Eligibility Essential Hypertension NCT01599104

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
Description

Mild hypertension untreated | Moderate hypertension untreated | Hypertension, mild | Hypertension, moderate | Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3276943
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1969581
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C3276943
UMLS CUI [4]
C1969581
UMLS CUI [5]
C0585941
treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and < 180 mmhg at the randomization visit (visit 201) and mssbp ≥140 mmhg < 180 mmhg at the visit immediately proceeding visit 201 (visit 102 or 103).
Description

Patients Treated | Antihypertensive therapy | Sitting systolic blood pressure mean | Randomization Visit | Visit preceding

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0585941
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C0034656
UMLS CUI [4,2]
C0008952
UMLS CUI [5,1]
C0008952
UMLS CUI [5,2]
C0332152
untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and < 180 mmhg at both visit 1 and visit 201.
Description

Patients untreated | Essential Hypertension Newly Diagnosed | History of hypertension | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C1518321
UMLS CUI [3]
C0455527
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
patients must have an absolute difference of ≤15 mmhg in mssbp between visit 201 and the immediately preceding visit;
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1705242
UMLS CUI [1,2]
C1319893
UMLS CUI [1,3]
C0444504
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0008952
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0332152
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg).
Description

Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
history of angioedema, drug-related or otherwise, as reported by the patient.
Description

Angioedema Drug-induced | Angioedema

Data type

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0458082
UMLS CUI [2]
C0002994
history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
Description

Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Aortic coarctation | Conn Syndrome | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases | Hypertensive disease Drug-induced

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0264649
UMLS CUI [3]
C0020545
UMLS CUI [4]
C0856759
UMLS CUI [5]
C0856760
UMLS CUI [6]
C0003492
UMLS CUI [7]
C1384514
UMLS CUI [8]
C0221406
UMLS CUI [9]
C0031511
UMLS CUI [10]
C0022680
UMLS CUI [11,1]
C0020538
UMLS CUI [11,2]
C0458082
patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch.
Description

Study Subject Participation Status | LCZ 696 Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2933615
UMLS CUI [2,2]
C0008976
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 Essential Hypertension NCT01599104

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mild hypertension untreated | Moderate hypertension untreated | Hypertension, mild | Hypertension, moderate | Antihypertensive therapy
Item
patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
boolean
C3276943 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1969581 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C3276943 (UMLS CUI [3])
C1969581 (UMLS CUI [4])
C0585941 (UMLS CUI [5])
Patients Treated | Antihypertensive therapy | Sitting systolic blood pressure mean | Randomization Visit | Visit preceding
Item
treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and < 180 mmhg at the randomization visit (visit 201) and mssbp ≥140 mmhg < 180 mmhg at the visit immediately proceeding visit 201 (visit 102 or 103).
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0034656 (UMLS CUI [4,1])
C0008952 (UMLS CUI [4,2])
C0008952 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
Patients untreated | Essential Hypertension Newly Diagnosed | History of hypertension | Sitting systolic blood pressure mean
Item
untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥ 150 mmhg and < 180 mmhg at both visit 1 and visit 201.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0455527 (UMLS CUI [3])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
Difference Sitting systolic blood pressure mean | Randomization Visit | Visit preceding
Item
patients must have an absolute difference of ≤15 mmhg in mssbp between visit 201 and the immediately preceding visit;
boolean
C1705242 (UMLS CUI [1,1])
C1319893 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg).
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Angioedema Drug-induced | Angioedema
Item
history of angioedema, drug-related or otherwise, as reported by the patient.
boolean
C0002994 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0002994 (UMLS CUI [2])
Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Aortic coarctation | Conn Syndrome | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases | Hypertensive disease Drug-induced
Item
history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
boolean
C0155616 (UMLS CUI [1])
C0264649 (UMLS CUI [2])
C0020545 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0856760 (UMLS CUI [5])
C0003492 (UMLS CUI [6])
C1384514 (UMLS CUI [7])
C0221406 (UMLS CUI [8])
C0031511 (UMLS CUI [9])
C0022680 (UMLS CUI [10])
C0020538 (UMLS CUI [11,1])
C0458082 (UMLS CUI [11,2])
Study Subject Participation Status | LCZ 696 Clinical Trial
Item
patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch.
boolean
C2348568 (UMLS CUI [1])
C2933615 (UMLS CUI [2,1])
C0008976 (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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