ID

12600

Descripción

A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF); ODM derived from: https://clinicaltrials.gov/show/NCT01067859

Link

https://clinicaltrials.gov/show/NCT01067859

Palabras clave

  1. 4/12/15 4/12/15 -
Subido en

4 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Acute Heart Failure NCT01067859

Eligibility Acute Heart Failure NCT01067859

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, age >/= 18 years of age;
Descripción

non-pregnant, non-lactating women or women without childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
Postmenopausal women aged 18 years or older.
Descripción

Postmenopausal women

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
Descripción

adequate contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
Descripción

subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
Descripción

subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1821820
UMLS CUI [2]
C0019993
dyspnea
Descripción

dyspnea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013404
clinical evidence of volume overload
Descripción

clinical evidence of volume overload

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2236137
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnancy or breastfeeding
Descripción

Pregnancy or breastfeeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute de-novo heart failure
Descripción

acute new heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0742752
acute myocardial infarction and/or myocardial infarction within 30 days
Descripción

acute myocardial infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155626
valvular heart disease requiring surgical intervention during the course of the study
Descripción

valvular heart disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018824
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Descripción

heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0018824
UMLS CUI [3]
C0152021
primary hypertrophic cardiomyopathy
Descripción

primary hypertrophic cardiomyopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264847
acute inflammatory heart disease, eg, acute myocarditis
Descripción

acute inflammatory heart disease, eg, acute myocarditis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0031046
UMLS CUI [3]
C0014118
unstable angina requiring angiography
Descripción

unstable angina

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965

Similar models

Eligibility Acute Heart Failure NCT01067859

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Patient age and sex
Item
male and female subjects, age >/= 18 years of age;
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal women
Item
Postmenopausal women aged 18 years or older.
boolean
C0232970 (UMLS CUI [1])
adequate contraceptive methods
Item
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
boolean
C0700589 (UMLS CUI [1])
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
Item
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
boolean
C0018802 (UMLS CUI [1])
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study
Item
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
boolean
C1821820 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
dyspnea
Item
dyspnea
boolean
C0013404 (UMLS CUI [1])
clinical evidence of volume overload
Item
clinical evidence of volume overload
boolean
C2236137 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
acute new heart failure
Item
acute de-novo heart failure
boolean
C0742752 (UMLS CUI [1])
acute myocardial infarction
Item
acute myocardial infarction and/or myocardial infarction within 30 days
boolean
C0155626 (UMLS CUI [1])
valvular heart disease
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1])
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Item
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
boolean
C0018801 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
C0152021 (UMLS CUI [3])
primary hypertrophic cardiomyopathy
Item
primary hypertrophic cardiomyopathy
boolean
C0264847 (UMLS CUI [1])
acute inflammatory heart disease, eg, acute myocarditis
Item
acute inflammatory heart disease, eg, acute myocarditis
boolean
C0155686 (UMLS CUI [1])
C0031046 (UMLS CUI [2])
C0014118 (UMLS CUI [3])
unstable angina
Item
unstable angina requiring angiography
boolean
C0002965 (UMLS CUI [1])

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