ID

42683

Description

Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00099450

Link

https://clinicaltrials.gov/show/NCT00099450

Keywords

Versions (2)
  1. 7/25/16 7/25/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00099450

English

Eligibility Cardiovascular Disease NCT00099450

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have body mass index (bmi) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg.
Description

Body mass index | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
if female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma).
Description

Disease Clinical Significance | Coronary Artery Disease | Diabetes Mellitus | Chronic Kidney Insufficiency | Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0403447
UMLS CUI [5]
C0004096
have major surgery within eight weeks of dosing.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
have overt viral illness within four weeks of dosing.
Description

Virus Disease

Data type

boolean

Alias
UMLS CUI [1]
C0042769
have tendency or history in family of tendency for bleeding.
Description

Bleeding tendency | Bleeding tendency Family history

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C1458140
UMLS CUI [2,2]
C0241889
have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis).
Description

Laboratory test result abnormal Clinical Significance | Chemistry abnormal | Hematology finding abnormal | Urinalysis abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0740327
UMLS CUI [3]
C0475182
UMLS CUI [4]
C0438142
have taken aspirin or any other non-steroidal anti-inflammatory drug (nsaid) within 10 days prior to admission to study facility.
Description

Aspirin | Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0003211
have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin k antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor xa inhibitors)
Description

medical condition | Antiplatelet Agents | clopidogrel | Ticlopidine | Dipyridamole | tirofiban | eptifibatide | abciximab | Adenosine | Epoprostenol | Anticoagulants | Vitamin K Antagonist | thrombin inhibitors | Heparin | Hirudin | argatroban | Factor Xa inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0085826
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0040207
UMLS CUI [5]
C0012582
UMLS CUI [6]
C0247025
UMLS CUI [7]
C0253563
UMLS CUI [8]
C0288672
UMLS CUI [9]
C0001443
UMLS CUI [10]
C0033567
UMLS CUI [11]
C0003280
UMLS CUI [12]
C2267235
UMLS CUI [13]
C2746042
UMLS CUI [14]
C0019134
UMLS CUI [15]
C0019573
UMLS CUI [16]
C0048470
UMLS CUI [17]
C3669283
have a clinically significant ecg abnormality.
Description

ECG abnormality Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
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Similar models

Eligibility Cardiovascular Disease NCT00099450

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index | Body Weight
Item
have body mass index (bmi) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
if female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Disease Clinical Significance | Coronary Artery Disease | Diabetes Mellitus | Chronic Kidney Insufficiency | Asthma
Item
have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma).
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0403447 (UMLS CUI [4])
C0004096 (UMLS CUI [5])
major surgery
Item
have major surgery within eight weeks of dosing.
boolean
C0679637 (UMLS CUI [1])
Virus Disease
Item
have overt viral illness within four weeks of dosing.
boolean
C0042769 (UMLS CUI [1])
Bleeding tendency | Bleeding tendency Family history
Item
have tendency or history in family of tendency for bleeding.
boolean
C1458140 (UMLS CUI [1])
C1458140 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Laboratory test result abnormal Clinical Significance | Chemistry abnormal | Hematology finding abnormal | Urinalysis abnormal
Item
have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis).
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0740327 (UMLS CUI [2])
C0475182 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
Aspirin | Anti-Inflammatory Agents, Non-Steroidal
Item
have taken aspirin or any other non-steroidal anti-inflammatory drug (nsaid) within 10 days prior to admission to study facility.
boolean
C0004057 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
medical condition | Antiplatelet Agents | clopidogrel | Ticlopidine | Dipyridamole | tirofiban | eptifibatide | abciximab | Adenosine | Epoprostenol | Anticoagulants | Vitamin K Antagonist | thrombin inhibitors | Heparin | Hirudin | argatroban | Factor Xa inhibitors
Item
have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin k antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor xa inhibitors)
boolean
C3843040 (UMLS CUI [1])
C0085826 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0040207 (UMLS CUI [4])
C0012582 (UMLS CUI [5])
C0247025 (UMLS CUI [6])
C0253563 (UMLS CUI [7])
C0288672 (UMLS CUI [8])
C0001443 (UMLS CUI [9])
C0033567 (UMLS CUI [10])
C0003280 (UMLS CUI [11])
C2267235 (UMLS CUI [12])
C2746042 (UMLS CUI [13])
C0019134 (UMLS CUI [14])
C0019573 (UMLS CUI [15])
C0048470 (UMLS CUI [16])
C3669283 (UMLS CUI [17])
ECG abnormality Clinical Significance
Item
have a clinically significant ecg abnormality.
boolean
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
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