ID

28757

Beschreibung

Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019); ODM derived from: https://clinicaltrials.gov/show/NCT00685776

Link

https://clinicaltrials.gov/show/NCT00685776

Stichworte

Versionen (1)
  1. 02.02.18 02.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Februar 2018

DOI

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Eligibility Coronary Heart Disease (CHD) NCT00685776

Englisch

Eligibility Coronary Heart Disease (CHD) NCT00685776

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
base study:
Beschreibung

Base Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705938
UMLS CUI [1,2]
C0008976
patient has coronary heart disease (chd) or chd risk-equivalent disease and is treated with a statin, with well controlled ldl-c
Beschreibung

Coronary heart disease | Disease Risk Equivalent | Statin | LDL Cholesterol Well controlled

Datentyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205163
UMLS CUI [3]
C0360714
UMLS CUI [4,1]
C0023824
UMLS CUI [4,2]
C3853142
extension study:
Beschreibung

Extension Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
Beschreibung

Base Clinical Trial Completed | Reversibility Time period Including

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705938
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0449261
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0332257
patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study
Beschreibung

Statins | LIPID MODIFYING AGENTS

Datentyp

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C3653535
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
Beschreibung

Heart failure | Cardiac Arrhythmia | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Blood Pressure Uncontrolled | Hypercholesterolemia Uncontrolled | Liver diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0038454
UMLS CUI [6,1]
C0005823
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0020443
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0023895
history of mental instability, drug/alcohol abuse within the past 5 years
Beschreibung

Instability mental | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0229992
UMLS CUI [2]
C0038586
pregnant or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of cancer within the last 5 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
donated blood products within 8 weeks
Beschreibung

Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
currently participating or have participated in a study with an investigational compound within the last 30 days
Beschreibung

Study Subject Participation Status | Compound Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1706082
UMLS CUI [2,2]
C1517586
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Ähnliche Modelle

Eligibility Coronary Heart Disease (CHD) NCT00685776

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Base Clinical Trial
Item
base study:
boolean
C1705938 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Coronary heart disease | Disease Risk Equivalent | Statin | LDL Cholesterol Well controlled
Item
patient has coronary heart disease (chd) or chd risk-equivalent disease and is treated with a statin, with well controlled ldl-c
boolean
C0010068 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0360714 (UMLS CUI [3])
C0023824 (UMLS CUI [4,1])
C3853142 (UMLS CUI [4,2])
Extension Clinical Trial
Item
extension study:
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Base Clinical Trial Completed | Reversibility Time period Including
Item
patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
boolean
C1705938 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0449261 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0332257 (UMLS CUI [2,3])
Statins | LIPID MODIFYING AGENTS
Item
patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study
boolean
C0360714 (UMLS CUI [1])
C3653535 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Heart failure | Cardiac Arrhythmia | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Blood Pressure Uncontrolled | Hypercholesterolemia Uncontrolled | Liver diseases
Item
history of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
boolean
C0018801 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0005823 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0020443 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8])
Instability mental | Substance Use Disorders
Item
history of mental instability, drug/alcohol abuse within the past 5 years
boolean
C1444783 (UMLS CUI [1,1])
C0229992 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms
Item
history of cancer within the last 5 years
boolean
C0006826 (UMLS CUI [1])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Blood Donation
Item
donated blood products within 8 weeks
boolean
C0005794 (UMLS CUI [1])
Study Subject Participation Status | Compound Investigational
Item
currently participating or have participated in a study with an investigational compound within the last 30 days
boolean
C2348568 (UMLS CUI [1])
C1706082 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
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