ID

39493

Beschreibung

A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01944683

Link

https://clinicaltrials.gov/show/NCT01944683

Stichworte

Versionen (1)
  1. 18.01.20 18.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01944683

Englisch

Eligibility Heart Failure NCT01944683

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
if female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
Beschreibung

Postmenopausal state Duration | Bilateral oophorectomy | Hysterectomy | Female sterility

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0278321
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0917730
if male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
Beschreibung

Male sterility | Vasectomy | Gender Barrier Contraception | Sperm donation Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0917731
UMLS CUI [2]
C0042387
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0004764
UMLS CUI [4,1]
C0871414
UMLS CUI [4,2]
C0332197
stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
Beschreibung

Coronary heart disease Stable | Unstable Angina Absent | Acute Coronary Syndrome Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0948089
UMLS CUI [3,2]
C0332197
all cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to day 1
Beschreibung

Pharmaceutical Preparations cardiac Dose Stable | Adrenergic beta-1 Receptor Antagonists | Renin-angiotensin system inhibitors | Aldosterone Antagonists | Hydralazine | Nitrates

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2]
C0304516
UMLS CUI [3,1]
C0035096
UMLS CUI [3,2]
C0243077
UMLS CUI [4]
C0002007
UMLS CUI [5]
C0020223
UMLS CUI [6]
C0028125
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous exposure to ggf2 or other neuregulins
Beschreibung

Exposure to GGF2 | Exposure to Neuregulins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1448481
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0752253
initiation or change of a prescription medication within the 2 weeks prior to day 1, and/or concomitant medication regimen is expected to change during the course of the study
Beschreibung

Initiation Prescription Drugs | Change Prescription Drugs | Pharmacotherapy Change Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0304227
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0304227
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1517001
known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of ggf2 diluent
Beschreibung

Midazolam allergy | Allergic Reaction Midazolam Syrup Component | Allergic Reaction Cherry Flavor | Allergic Reaction GGF2 diluent Component

Datentyp

boolean

Alias
UMLS CUI [1]
C0570821
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0026056
UMLS CUI [2,3]
C0991550
UMLS CUI [2,4]
C1705248
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0770609
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1448481
UMLS CUI [4,3]
C0304221
UMLS CUI [4,4]
C1705248
known specific hepatic disease; total bilirubin >2 mg/dl, ast > 100 iu
Beschreibung

Liver disease | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
history of hepatic impairment (hepatitis b and c)
Beschreibung

Hepatic impairment | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
type i diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
documented stroke or transient ischemic attack (tia) within 2 months of study enrollment
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
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Ähnliche Modelle

Eligibility Heart Failure NCT01944683

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state Duration | Bilateral oophorectomy | Hysterectomy | Female sterility
Item
if female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0278321 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0917730 (UMLS CUI [4])
Male sterility | Vasectomy | Gender Barrier Contraception | Sperm donation Absent
Item
if male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
boolean
C0917731 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0871414 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Coronary heart disease Stable | Unstable Angina Absent | Acute Coronary Syndrome Absent
Item
stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
boolean
C0010068 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0948089 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pharmaceutical Preparations cardiac Dose Stable | Adrenergic beta-1 Receptor Antagonists | Renin-angiotensin system inhibitors | Aldosterone Antagonists | Hydralazine | Nitrates
Item
all cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to day 1
boolean
C0013227 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0304516 (UMLS CUI [2])
C0035096 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C0002007 (UMLS CUI [4])
C0020223 (UMLS CUI [5])
C0028125 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Exposure to GGF2 | Exposure to Neuregulins
Item
any previous exposure to ggf2 or other neuregulins
boolean
C0332157 (UMLS CUI [1,1])
C1448481 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0752253 (UMLS CUI [2,2])
Initiation Prescription Drugs | Change Prescription Drugs | Pharmacotherapy Change Expected
Item
initiation or change of a prescription medication within the 2 weeks prior to day 1, and/or concomitant medication regimen is expected to change during the course of the study
boolean
C1704686 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0304227 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Midazolam allergy | Allergic Reaction Midazolam Syrup Component | Allergic Reaction Cherry Flavor | Allergic Reaction GGF2 diluent Component
Item
known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of ggf2 diluent
boolean
C0570821 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0026056 (UMLS CUI [2,2])
C0991550 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0770609 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C1448481 (UMLS CUI [4,2])
C0304221 (UMLS CUI [4,3])
C1705248 (UMLS CUI [4,4])
Liver disease | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
known specific hepatic disease; total bilirubin >2 mg/dl, ast > 100 iu
boolean
C0023895 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Hepatic impairment | Hepatitis B | Hepatitis C
Item
history of hepatic impairment (hepatitis b and c)
boolean
C0948807 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes
boolean
C0011854 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
documented stroke or transient ischemic attack (tia) within 2 months of study enrollment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
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