Eligibility Hypertension NCT02242318

1 Formulare

StudyEvent: Eligibility
1. Eligibility Hypertension NCT02242318

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

mild-to-moderate hypertension

Item

1. mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmhg and ≤ 109 mmhg, measured by manual cuff sphygmomanometer, at visit 2

boolean

C3276943 (UMLS CUI [1])
C1969581 (UMLS CUI [2])

diastolic blood pressure

Item

2. 24-hour mean dbp of ≥ 85 mmhg at visit 3 as measured by abpm

boolean

C0428883 (UMLS CUI [1])

age

Item

3. age 18 years or older

boolean

C0001779 (UMLS CUI [1])

ability to stop any current antihypertensive therapy without risk to the patient

Item

4. ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)

boolean

C0585941 (UMLS CUI [1])

written informed consent

Item

5. patient's written informed consent in accordance with good clinical practice (gcp) and local legislation

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

pre-menopausal women

Item

1. pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who

boolean

C0043210 (UMLS CUI [1,1])
C0279752 (UMLS CUI [1,2])

are not surgically sterile

Item

1. are not surgically sterile,

boolean

C0021359 (UMLS CUI [1])

nursing

Item

2. are nursing,

boolean

C0006147 (UMLS CUI [1])

contraception

Item

3. are of child-bearing potential and are not practising acceptable methods of birth control, or do not plan to continue practising an acceptable method throughout the study. acceptable methods of birth control include oral, implantable or injectable contraceptives and intra uterine devices (iud)

boolean

C0700589 (UMLS CUI [1])

known or suspected secondary hypertension

Item

2. known or suspected secondary hypertension

boolean

sitting systolic blood pressure

Item

3. mean sitting sbp ≥180 mmhg or mean sitting dbp ≥110 mmhg during any visit of the placebo run-in period

boolean

C1319893 (UMLS CUI [1])

hepatic and/or renal dysfunction

Item

4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:

boolean

C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])

AST and ALT level

Item

1. serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) > than 2 times the upper limit of normal range,

boolean

C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])

serum creatinine

Item

2. serum creatinine > 2.3 mg/dl (or > 203 μmol/l)

boolean

C0201976 (UMLS CUI [1])

renal artery stenosis, postrenal transplant or with only one kidney

Item

5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney

boolean

C0035067 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0426706 (UMLS CUI [3])

sodium depletion, hypokalaemia or hyperkalaemia

Item

6. clinically relevant sodium depletion, hypokalaemia or hyperkalaemia

boolean

C0020625 (UMLS CUI [1])
C0020621 (UMLS CUI [2])
C0020461 (UMLS CUI [3])

uncorrected volume depletion

Item

7. uncorrected volume depletion

boolean

C0546884 (UMLS CUI [1])

primary aldosteronism

Item

8. primary aldosteronism

boolean

C1719312 (UMLS CUI [1])

hereditary fructose intolerance

Item

9. hereditary fructose intolerance

boolean

C0016751 (UMLS CUI [1])

biliary obstructive disorders

Item

10. biliary obstructive disorders

boolean

C0400979 (UMLS CUI [1])

angioedema during treatment with ace inhibitors or angiotensin II receptor antagonists

Item

11. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists

boolean

C0570450 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C1319923 (UMLS CUI [2,1])
C0002994 (UMLS CUI [2,2])

substance use disorder

Item

12. history of drug or alcohol dependency within six months prior to start of run-in period

boolean

C0038586 (UMLS CUI [1])

concomitant administration of any medications known to affect blood pressure

Item

13. concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol

boolean

C0003364 (UMLS CUI [1])

any investigational therapy

Item

14. any investigational therapy within one month of signing the informed consent form

boolean

C1548937 (UMLS CUI [1])

congestive heart failure

Item

15. congestive heart failure (new york heart association (nyha) functional class congestive heart failure (chf iii-iv))

boolean

C0018802 (UMLS CUI [1])

unstable angina

Item

16. unstable angina within the past three months prior to start of run-in period

boolean

C0002965 (UMLS CUI [1])

stroke

Item

17. stroke within the past six months prior to start of run-in period

boolean

C0038454 (UMLS CUI [1])

myocardial infarction or cardiac surgery

Item

18. myocardial infarction or cardiac surgery within the past three months prior to start of run-in period

boolean

C0027051 (UMLS CUI [1])
C0018821 (UMLS CUI [2])

ptca

Item

19. percutaneous transluminal coronary angioplasty (ptca) within the past three months prior to start of run-in period

boolean

C2936173 (UMLS CUI [1])

arrhythmias

Item

20. sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator

boolean

C0003811 (UMLS CUI [1])

hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

Item

21. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

boolean

C0007194 (UMLS CUI [1])
C0003499 (UMLS CUI [2])
C0003507 (UMLS CUI [3])
C0026269 (UMLS CUI [4])

uncontrolled diabetes mellitus hba1c

Item

22. patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c ≥ 10%

boolean

C0743131 (UMLS CUI [1,1])
C0202054 (UMLS CUI [1,2])

night shift workers who routinely sleep during the daytime

Item

23. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (am)

boolean

C0555008 (UMLS CUI [1,1])
C4075948 (UMLS CUI [1,2])

hypersensitivity to any component of the formulations

Item

24. known hypersensitivity to any component of the formulations

boolean

C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

clinical condition compromising study protocol

Item

25. any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication

boolean

C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])

inability to comply with the protocol

Item

26. inability to comply with the protocol

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

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Eligibility Hypertension NCT02242318