ID

24179

Descrizione

Safety and Pharmacodynamic Study of CD-NP; ODM derived from: https://clinicaltrials.gov/show/NCT00482937

collegamento

https://clinicaltrials.gov/show/NCT00482937

Keywords

versioni (1)
  1. 27/07/17 27/07/17 -
Caricato su

27 luglio 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00482937

Inglese

Eligibility Heart Failure, Congestive NCT00482937

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
be a healthy male using reliable contraception, a post-menopausal female, or a surgically sterilized female 18 to 60 years of age
Descrizione

Gender Healthy Contraceptive methods | Postmenopausal state | Female Sterilization | Age

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0001779
have a bmi within the range of 18–34 kg/m2
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
be able to communicate effectively with the study personnel
Descrizione

Able to communicate Study Personnel

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C2985653
have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic
Descrizione

Disease Absent | Laboratory test result abnormal Absent | Medical History | Physical Examination | Laboratory data interpretation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0031809
UMLS CUI [5]
C0262707
have a normal 12-lead electrocardiogram, without any clinically significant abnormalities
Descrizione

12 lead ECG Normal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
be nonsmokers defined as not having smoked in the past 6 months
Descrizione

Non-smoker

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0337672
be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity or allergy to cd-np or its components, nesiritide, other natriuretic peptides, or related compounds
Descrizione

Hypersensitivity CD-NP | Hypersensitivity CD-NP Component | Hypersensitivity Nesiritide | Hypersensitivity Natriuretic Peptides | Hypersensitivity Compound Related

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2717567
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2717567
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0054015
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1144709
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1706082
UMLS CUI [5,3]
C0439849
women who are pregnant or breast-feeding
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
Descrizione

Condition compromises Hematological system | Condition compromises Cardiovascular system | Condition compromises Pulmonary system | Condition compromises Renal system | Condition compromises Gastrointestinal system | Condition compromises Liver | Condition compromises Central Nervous System | Condition Interferes with Absorption Investigational New Drug | Condition Interferes with Distribution Investigational New Drug | Condition Interferes with Metabolism Investigational New Drug | Condition Interferes with Excretion Investigational New Drug | Condition Patient At risk Increased

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0279810
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0007226
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0884309
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0449913
UMLS CUI [4,4]
C0022646
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0012240
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0023884
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C3714787
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0678745
UMLS CUI [8,4]
C0013230
UMLS CUI [9,1]
C0348080
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C1378698
UMLS CUI [9,4]
C0013230
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0025520
UMLS CUI [10,4]
C0013230
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0683141
UMLS CUI [11,4]
C0013230
UMLS CUI [12,1]
C0348080
UMLS CUI [12,2]
C0030705
UMLS CUI [12,3]
C1444641
UMLS CUI [12,4]
C0205217
the presence of abnormal laboratory values which are considered clinically significant.
Descrizione

Laboratory test result abnormal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0438215
positive screen for hepatitis b (hbsag, hepatitis b surface antigen), hepatitis c (anti hcv, hepatitis c antibody), or hiv (anti-hiv 1/2).
Descrizione

Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive | HIV Seropositivity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
UMLS CUI [4]
C0281863
UMLS CUI [5]
C0019699
received an investigational drug within a period of 30 days prior to enrollment in the study.
Descrizione

Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013230
received any drug therapy within 1 week, or 5 half-lives, prior to administration of the first dose of any study-related treatment. this exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism. use of nsaids, sulfonamides, probenecid or other drugs known to alter renal or tubular function is specifically prohibited for at least 5 half-lives prior to the first dose of any study related treatment.
Descrizione

Pharmacotherapy | Pharmaceutical Preparations Causing Drug Metabolism Induction Hepatic | Pharmaceutical Preparations Causing Drug Metabolism Inhibition Hepatic | Anti-Inflammatory Agents, Non-Steroidal | Sulfonamides | Probenecid | Pharmaceutical Preparations Causing Renal alteration | Pharmaceutical Preparations Causing Renal tubular function Alteration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1512074
UMLS CUI [2,4]
C0205054
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C1512075
UMLS CUI [3,4]
C0205054
UMLS CUI [4]
C0003211
UMLS CUI [5]
C0038760
UMLS CUI [6]
C0033209
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0678227
UMLS CUI [7,3]
C0184571
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0678227
UMLS CUI [8,3]
C0678875
UMLS CUI [8,4]
C1515926
consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
Descrizione

Alcohol consumption

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001948
a positive urine drug screen including ethanol, cocaine, thc, barbiturates, amphetamines, benzodiazepines, and opiates.
Descrizione

Urine drug screen positive | Ethanol | Cocaine | THC | Barbiturates | Amphetamines | Benzodiazepines | Opiates

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0001962
UMLS CUI [3]
C0009170
UMLS CUI [4]
C0039663
UMLS CUI [5]
C0004745
UMLS CUI [6]
C0002667
UMLS CUI [7]
C0005064
UMLS CUI [8]
C0376196
a history (within the last 2 years) of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
Descrizione

Alcohol abuse | Illicit drug use | Mental disorders | Physical addiction Opioids | Drug abuse | Drug Dependence

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0004936
UMLS CUI [4,1]
C0278080
UMLS CUI [4,2]
C0242402
UMLS CUI [5]
C0013146
UMLS CUI [6]
C1510472
a history of difficulty with donating blood. donated blood or blood products within 45 days prior to enrollment
Descrizione

Blood Donation Difficulty with | Blood Donation | Blood product Donation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332218
UMLS CUI [2]
C0005794
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C0680854
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Similar models

Eligibility Heart Failure, Congestive NCT00482937

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender Healthy Contraceptive methods | Postmenopausal state | Female Sterilization | Age
Item
be a healthy male using reliable contraception, a post-menopausal female, or a surgically sterilized female 18 to 60 years of age
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Body mass index
Item
have a bmi within the range of 18–34 kg/m2
boolean
C1305855 (UMLS CUI [1])
Able to communicate Study Personnel
Item
be able to communicate effectively with the study personnel
boolean
C2364293 (UMLS CUI [1,1])
C2985653 (UMLS CUI [1,2])
Disease Absent | Laboratory test result abnormal Absent | Medical History | Physical Examination | Laboratory data interpretation
Item
have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic
boolean
C0012634 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0262707 (UMLS CUI [5])
12 lead ECG Normal
Item
have a normal 12-lead electrocardiogram, without any clinically significant abnormalities
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Non-smoker
Item
be nonsmokers defined as not having smoked in the past 6 months
boolean
C0337672 (UMLS CUI [1])
Informed Consent
Item
be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity CD-NP | Hypersensitivity CD-NP Component | Hypersensitivity Nesiritide | Hypersensitivity Natriuretic Peptides | Hypersensitivity Compound Related
Item
known hypersensitivity or allergy to cd-np or its components, nesiritide, other natriuretic peptides, or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C2717567 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2717567 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0054015 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1144709 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1706082 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition compromises Hematological system | Condition compromises Cardiovascular system | Condition compromises Pulmonary system | Condition compromises Renal system | Condition compromises Gastrointestinal system | Condition compromises Liver | Condition compromises Central Nervous System | Condition Interferes with Absorption Investigational New Drug | Condition Interferes with Distribution Investigational New Drug | Condition Interferes with Metabolism Investigational New Drug | Condition Interferes with Excretion Investigational New Drug | Condition Patient At risk Increased
Item
any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0279810 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0007226 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0884309 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0449913 (UMLS CUI [4,3])
C0022646 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0012240 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0023884 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C3714787 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0348080 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C1378698 (UMLS CUI [9,3])
C0013230 (UMLS CUI [9,4])
C0348080 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0025520 (UMLS CUI [10,3])
C0013230 (UMLS CUI [10,4])
C0348080 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0683141 (UMLS CUI [11,3])
C0013230 (UMLS CUI [11,4])
C0348080 (UMLS CUI [12,1])
C0030705 (UMLS CUI [12,2])
C1444641 (UMLS CUI [12,3])
C0205217 (UMLS CUI [12,4])
Laboratory test result abnormal
Item
the presence of abnormal laboratory values which are considered clinically significant.
boolean
C0438215 (UMLS CUI [1])
Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive screen for hepatitis b (hbsag, hepatitis b surface antigen), hepatitis c (anti hcv, hepatitis c antibody), or hiv (anti-hiv 1/2).
boolean
C0856706 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Investigational New Drugs
Item
received an investigational drug within a period of 30 days prior to enrollment in the study.
boolean
C0013230 (UMLS CUI [1])
Pharmacotherapy | Pharmaceutical Preparations Causing Drug Metabolism Induction Hepatic | Pharmaceutical Preparations Causing Drug Metabolism Inhibition Hepatic | Anti-Inflammatory Agents, Non-Steroidal | Sulfonamides | Probenecid | Pharmaceutical Preparations Causing Renal alteration | Pharmaceutical Preparations Causing Renal tubular function Alteration
Item
received any drug therapy within 1 week, or 5 half-lives, prior to administration of the first dose of any study-related treatment. this exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism. use of nsaids, sulfonamides, probenecid or other drugs known to alter renal or tubular function is specifically prohibited for at least 5 half-lives prior to the first dose of any study related treatment.
boolean
C0013216 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1512074 (UMLS CUI [2,3])
C0205054 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C1512075 (UMLS CUI [3,3])
C0205054 (UMLS CUI [3,4])
C0003211 (UMLS CUI [4])
C0038760 (UMLS CUI [5])
C0033209 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0184571 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0678875 (UMLS CUI [8,3])
C1515926 (UMLS CUI [8,4])
Alcohol consumption
Item
consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
boolean
C0001948 (UMLS CUI [1])
Urine drug screen positive | Ethanol | Cocaine | THC | Barbiturates | Amphetamines | Benzodiazepines | Opiates
Item
a positive urine drug screen including ethanol, cocaine, thc, barbiturates, amphetamines, benzodiazepines, and opiates.
boolean
C0743300 (UMLS CUI [1])
C0001962 (UMLS CUI [2])
C0009170 (UMLS CUI [3])
C0039663 (UMLS CUI [4])
C0004745 (UMLS CUI [5])
C0002667 (UMLS CUI [6])
C0005064 (UMLS CUI [7])
C0376196 (UMLS CUI [8])
Alcohol abuse | Illicit drug use | Mental disorders | Physical addiction Opioids | Drug abuse | Drug Dependence
Item
a history (within the last 2 years) of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
boolean
C0085762 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0278080 (UMLS CUI [4,1])
C0242402 (UMLS CUI [4,2])
C0013146 (UMLS CUI [5])
C1510472 (UMLS CUI [6])
Blood Donation Difficulty with | Blood Donation | Blood product Donation
Item
a history of difficulty with donating blood. donated blood or blood products within 45 days prior to enrollment
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
C0456388 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])
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