ID

24179

Description

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

Lien

https://clinicaltrials.gov/show/NCT00482937

Mots-clés

Versions (1)
  1. 27/07/2017 27/07/2017 -
Téléchargé le

27 juillet 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00482937

Anglais

Eligibility Heart Failure, Congestive NCT00482937

1 Formulaires  
Inclusion Criteria
Description

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
Description

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

Type de données

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
Description

Body mass index

Type de données

boolean

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

Able to communicate Study Personnel

Type de données

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
Description

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

Type de données

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
Description

12 lead ECG Normal

Type de données

boolean

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

Non-smoker

Type de données

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
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Type de données

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
Description

Pregnancy | Breast Feeding

Type de données

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
Description

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

Type de données

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.
Description

Laboratory test result abnormal

Type de données

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).
Description

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

Type de données

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.
Description

Investigational New Drugs

Type de données

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.
Description

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

Type de données

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.
Description

Alcohol consumption

Type de données

boolean

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

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

Type de données

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.
Description

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

Type de données

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
Description

Blood Donation Difficulty with | Blood Donation | Blood product Donation

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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