ID

30054

Beskrivning

International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia; ODM derived from: https://clinicaltrials.gov/show/NCT00876876

Länk

https://clinicaltrials.gov/show/NCT00876876

Nyckelord

Versioner (1)
  1. 2018-05-06 2018-05-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypervolemic Hyponatremia NCT00876876

Engelsk

Eligibility Hypervolemic Hyponatremia NCT00876876

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women with age greater than or equal to 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. prior successful participation in a randomized, blinded, placebo-controlled phase 3 lixivaptan study of hyponatremia in heart failure (protocol ck-lx3401) with evidence of continued need for therapy as follows:
Beskrivning

Study Subject Participation Status | Lixivaptan | Hyponatremia Treatment required for | Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0676838
UMLS CUI [3,1]
C0020625
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C0018801
patient completed full course of treatment (e.g., either placebo or lixivaptan). treatment assignments for protocol ck-lx3401 will not be unblinded prior to participation in the extension study.
Beskrivning

Treatment completed | Placebo | Lixivaptan

Datatyp

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2]
C0032042
UMLS CUI [3]
C0676838
baseline serum sodium concentration < 135 meq/l following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
Beskrivning

Serum sodium measurement post treatment | Clinical Study Follow-up | Lixivaptan | Hyponatremia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0523891
UMLS CUI [1,2]
C2709088
UMLS CUI [2]
C3274571
UMLS CUI [3]
C0676838
UMLS CUI [4]
C0020625
3. the patient has clinical evidence of volume overload with at least one of the following:
Beskrivning

Fluid overload

Datatyp

boolean

Alias
UMLS CUI [1]
C0546817
dyspnea
Beskrivning

Dyspnea

Datatyp

boolean

Alias
UMLS CUI [1]
C0013404
pulmonary congestion (rales)
Beskrivning

Pulmonary congestion | Rales

Datatyp

boolean

Alias
UMLS CUI [1]
C0242073
UMLS CUI [2]
C0034642
peripheral edema
Beskrivning

Peripheral edema

Datatyp

boolean

Alias
UMLS CUI [1]
C0085649
increased jugular venous pressure and/or hepatic congestion with ascites
Beskrivning

Raised jugular venous pressure | Hepatic congestion | Ascites

Datatyp

boolean

Alias
UMLS CUI [1]
C0520861
UMLS CUI [2]
C0267821
UMLS CUI [3]
C0003962
chest x-ray consistent with chf; or
Beskrivning

Chest X-ray Consistent with Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0018802
plasma bnp ≥150 pg/ml or nt pro-bnp ≥ 450 pg/ml
Beskrivning

BNP in serum or plasma | NT-proBNP

Datatyp

boolean

Alias
UMLS CUI [1]
C4066092
UMLS CUI [2]
C0754710
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
Beskrivning

Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
2. inability to provide informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
3. acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
Beskrivning

Hyponatremia Severe | Symptoms Hyponatremia | Patient need for Intervention Immediate | Coma | Seizures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0020625
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0205253
UMLS CUI [4]
C0009421
UMLS CUI [5]
C0036572
4. acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
Beskrivning

Hyponatremia | Hyponatremia Transient | Hyponatremia Associated with Craniocerebral Trauma | Hyponatremia Postoperative state

Datatyp

boolean

Alias
UMLS CUI [1]
C0020625
UMLS CUI [2,1]
C0020625
UMLS CUI [2,2]
C0205374
UMLS CUI [3,1]
C0020625
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0018674
UMLS CUI [4,1]
C0020625
UMLS CUI [4,2]
C0231287
5. hyponatremia in hypovolemic states. hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
Beskrivning

HYPONATREMIA HYPOVOLEMIC

Datatyp

boolean

Alias
UMLS CUI [1]
C0745165
6. euvolemic hyponatremia (e.g., siadh, etc.). euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.
Beskrivning

HYPONATREMIA EUVOLEMIC | Inappropriate ADH Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0745159
UMLS CUI [2]
C0021141
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Similar models

Eligibility Hypervolemic Hyponatremia NCT00876876

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men and women with age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status | Lixivaptan | Hyponatremia Treatment required for | Heart failure
Item
2. prior successful participation in a randomized, blinded, placebo-controlled phase 3 lixivaptan study of hyponatremia in heart failure (protocol ck-lx3401) with evidence of continued need for therapy as follows:
boolean
C2348568 (UMLS CUI [1])
C0676838 (UMLS CUI [2])
C0020625 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4])
Treatment completed | Placebo | Lixivaptan
Item
patient completed full course of treatment (e.g., either placebo or lixivaptan). treatment assignments for protocol ck-lx3401 will not be unblinded prior to participation in the extension study.
boolean
C0580352 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
C0676838 (UMLS CUI [3])
Serum sodium measurement post treatment | Clinical Study Follow-up | Lixivaptan | Hyponatremia
Item
baseline serum sodium concentration < 135 meq/l following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
boolean
C0523891 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2])
C0676838 (UMLS CUI [3])
C0020625 (UMLS CUI [4])
Fluid overload
Item
3. the patient has clinical evidence of volume overload with at least one of the following:
boolean
C0546817 (UMLS CUI [1])
Dyspnea
Item
dyspnea
boolean
C0013404 (UMLS CUI [1])
Pulmonary congestion | Rales
Item
pulmonary congestion (rales)
boolean
C0242073 (UMLS CUI [1])
C0034642 (UMLS CUI [2])
Peripheral edema
Item
peripheral edema
boolean
C0085649 (UMLS CUI [1])
Raised jugular venous pressure | Hepatic congestion | Ascites
Item
increased jugular venous pressure and/or hepatic congestion with ascites
boolean
C0520861 (UMLS CUI [1])
C0267821 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Chest X-ray Consistent with Congestive heart failure
Item
chest x-ray consistent with chf; or
boolean
C0039985 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,3])
BNP in serum or plasma | NT-proBNP
Item
plasma bnp ≥150 pg/ml or nt pro-bnp ≥ 450 pg/ml
boolean
C4066092 (UMLS CUI [1])
C0754710 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling
Item
1. women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Informed Consent Unable
Item
2. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hyponatremia Severe | Symptoms Hyponatremia | Patient need for Intervention Immediate | Coma | Seizures
Item
3. acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
boolean
C0020625 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0020625 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205253 (UMLS CUI [3,3])
C0009421 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
Hyponatremia | Hyponatremia Transient | Hyponatremia Associated with Craniocerebral Trauma | Hyponatremia Postoperative state
Item
4. acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
boolean
C0020625 (UMLS CUI [1])
C0020625 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
C0020625 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0018674 (UMLS CUI [3,3])
C0020625 (UMLS CUI [4,1])
C0231287 (UMLS CUI [4,2])
HYPONATREMIA HYPOVOLEMIC
Item
5. hyponatremia in hypovolemic states. hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
boolean
C0745165 (UMLS CUI [1])
HYPONATREMIA EUVOLEMIC | Inappropriate ADH Syndrome
Item
6. euvolemic hyponatremia (e.g., siadh, etc.). euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.
boolean
C0745159 (UMLS CUI [1])
C0021141 (UMLS CUI [2])
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