ID

29964

Beskrivning

Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00772577

Länk

https://clinicaltrials.gov/show/NCT00772577

Nyckelord

Versioner (2)
  1. 2018-04-30 2018-04-30 -
  2. 2018-04-30 2018-04-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT00772577

Engelsk

Eligibility Hypertension NCT00772577

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Beskrivning

Study Subject Participation Status eligible | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
male or female outpatients, 18 years of age and older.
Beskrivning

Outpatients | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with stage 2 hypertension. patients must have a mssbp ≥ 160 mmhg and < 200 mmhg at study visit 5 (randomization).
Beskrivning

Hypertensive disease Stage | Sitting systolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
patients must have a bmi ≥ 30 kg/m2 but ≤ 45 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and/or mssbp ≥ 200 mmhg) at any visit.
Beskrivning

Blood pressure determination | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
use of aliskiren and/or a fixed dose combination of aliskiren hctz or participation in a clinical trial that had aliskiren and/or aliskiren hctz as treatment within 30 days of visit 1.
Beskrivning

Aliskiren | Hydrochlorothiazide | Combined Modality Therapy Dose Stable | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1120110
UMLS CUI [2]
C0020261
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C2348568
history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ace inhibitors or renin inhibitors) as the study drugs.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Same | Angiotensin-Converting Enzyme Inhibitors | Renin inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C3858838
UMLS CUI [2,4]
C0445247
UMLS CUI [3]
C0003015
UMLS CUI [4]
C1960108
history or evidence of a secondary form of hypertension.
Beskrivning

Secondary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmhg). therapy with a fixed dose combination of two active substances represent two drugs.
Beskrivning

Refractory hypertension | Pharmacotherapy Triple Unresponsive to Treatment | Pharmaceutical Preparations Maximum Tolerated Dose | Diuretics | Blood Pressure Goal failed | Combined Modality Therapy | Pharmaceutical Preparations Quantity Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0860493
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205174
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0752079
UMLS CUI [4]
C0012798
UMLS CUI [5,1]
C0005823
UMLS CUI [5,2]
C0679840
UMLS CUI [5,3]
C0231175
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
patients on 4 or more antihypertensive medications.
Beskrivning

Antihypertensive Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
long qt syndrome or qtc > 450 msec for males and > 470 msec for females at screening.
Beskrivning

Long QT Syndrome | QTc Duration | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2,1]
C0860814
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0079399
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

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

Eligibility Hypertension NCT00772577

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Outpatients | Age
Item
male or female outpatients, 18 years of age and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease Stage | Sitting systolic blood pressure mean
Item
patients with stage 2 hypertension. patients must have a mssbp ≥ 160 mmhg and < 200 mmhg at study visit 5 (randomization).
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Body mass index
Item
patients must have a bmi ≥ 30 kg/m2 but ≤ 45 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Blood pressure determination | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and/or mssbp ≥ 200 mmhg) at any visit.
boolean
C0005824 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Investigational New Drugs
Item
use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
boolean
C0013230 (UMLS CUI [1])
Aliskiren | Hydrochlorothiazide | Combined Modality Therapy Dose Stable | Study Subject Participation Status
Item
use of aliskiren and/or a fixed dose combination of aliskiren hctz or participation in a clinical trial that had aliskiren and/or aliskiren hctz as treatment within 30 days of visit 1.
boolean
C1120110 (UMLS CUI [1])
C0020261 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Same | Angiotensin-Converting Enzyme Inhibitors | Renin inhibitor
Item
history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ace inhibitors or renin inhibitors) as the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C3858838 (UMLS CUI [2,3])
C0445247 (UMLS CUI [2,4])
C0003015 (UMLS CUI [3])
C1960108 (UMLS CUI [4])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Refractory hypertension | Pharmacotherapy Triple Unresponsive to Treatment | Pharmaceutical Preparations Maximum Tolerated Dose | Diuretics | Blood Pressure Goal failed | Combined Modality Therapy | Pharmaceutical Preparations Quantity Dose Stable
Item
refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmhg). therapy with a fixed dose combination of two active substances represent two drugs.
boolean
C0860493 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0205174 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4])
C0005823 (UMLS CUI [5,1])
C0679840 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0009429 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
Antihypertensive Agents Quantity
Item
patients on 4 or more antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Long QT Syndrome | QTc Duration | Gender
Item
long qt syndrome or qtc > 450 msec for males and > 470 msec for females at screening.
boolean
C0023976 (UMLS CUI [1])
C0860814 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
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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