Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
inclusion criteria
Item
Adult males or females who are between 18 and 55 years of age
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
Body weight > 60 kg (132 pounds) and body mass index (BMI) between 19 and 32 where: BMI = weight in kg(height in meters)2
boolean
C1305855 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
A signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions
boolean
C0525058 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
exclusion criteria
Item
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
boolean
C1142435 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Subjects who are poor metabolizers of CYP2D6 as determined at screening
boolean
C3888904 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements, as well as grapefruit containing products) within 7 days or 5 half-lives (whichever is longer) prior to first dose of study medication. Excluded from this list is acetaminophen at doses of <2 grams/day. Hormonal methods of contraception (including oral contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraception methods) and hormone replacement therapy must be discontinued within thirty days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Depo-Provera must be discontinued at least 6 months prior to the first study period.
boolean
C0013227 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Positive urine drug screen (UDS) including alcohol at screening.
boolean
C0743300 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with an investigational drug within 30 days or five half-lives, whichever is longer, prior to the first dose of study medication (this includes investigational formulations of marketed products).
boolean
C0304229 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Consumption of grapefruit, grapefruit juice within 7 days prior to dosing
boolean
C0452456 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Pregnant or nursing female subjects; as well as female subjects of childbearing potential who are unwilling or unable to use appropriate forms of contraception (see Section 7 for details) from 14 days prior to dosing in Period 1 until the follow-up visit; or who are unwilling to abstain from sexual activity for the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
For female subjects, a positive serum β-hCG (human chorionic gonadotropin) test at screening or prior to dosing in any of the study periods.
boolean
C0032976 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Resting heart rate of < 45 beats per minute (bpm) at screening.
boolean
C0018810 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Any of the following abnormalities on 12-lead ECG during screening: • conduction abnormalities denoted by any of the following: • PR interval < 120 msec or > 200 msec • non-specific IVCD (intra-ventricular conduction delay) with QRS duration > 110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB) • incomplete RBBB as defined by QRS duration >100 msec but < 120 msec with RBBB pattern • Complete RBBB and LBBB • evidence of second- or third- degree AV block • pathological Q-waves (Q-wave wider than 0.04 sec or depth not greater than 0.4-0.5 mV) • evidence of ventricular pre-excitation • evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, left bundle branch block and/or right bundle branch block • QTcB interval > 430 msec for males or > 450 msec for female
boolean
C0522055 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Documented history of low blood pressure (average SBP < 110 mm Hg and/or DBP < 50 mm Hg) or blood pressure below theses values at time of screening.
boolean
C0005823 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Orthostatic hypotension diagnosed at screening (orthostatic hypotension will be defined as a reduction in systolic blood pressure of 20 mmHg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more for standing vs. supine measurements).
boolean
C0020651 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Blood collection of greater than 500 mL within 56 days prior to study start.
boolean
C0005834 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of asthma and/or COPD and/or hypersensitivity to β-adrenergic blocking agents.
boolean
C0004096 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of sensitivity to heparin, heparin- induced thrombocytopenia, or sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Subjects not willing and able to follow the procedures outlined in the protocol or who are unable to provide written informed consent.
boolean
C1321605 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of sensitivity to carvedilol (or chemically-related drugs), alpha-blockers or beta-blockers.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with any PDE5 inhibitors (such as but not limited to vardenafil, sildenafil, tadalafil) two weeks prior to dose and throughout study (follow-up visit).
boolean
C1318700 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Date of Vital signs
Item
Date of Vital signs
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time of Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Code List
Planned Relative Time of Vital Signs
Actual Time of Vital Signs
Item
Actual Time of Vital Signs
time
C2826762 (UMLS CUI [1])
systolic Blood pressure
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
diastolic Blood pressure
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Code List
Subject Position
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Planned relative time of ECG
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Code List
Planned relative time of ECG
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Haematology sample taken
Item
Haematology sample taken?
boolean
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Date Haematology sample taken
Item
Date Haematology sample taken
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Chemistry Sample taken
Item
Clinical Chemistry Sample taken?
boolean
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urinalysis sample taken
Item
Urinalysis sample taken
boolean
C0042014 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])