Safety and Tolerability of MK-5478 in Participants With H... | NCT01025843 | Trialant
NCT01025843
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 21, 2018Actual
Enrollment
20Actual
Phase
Phase 1
Conditions
Hypertension
Interventions
MK-5478
Comparator: Candesartan cilexetil
Comparator: Pbo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01025843
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5478-001
Secondary IDs
ID
Type
Description
Link
2009-016048-38
EudraCT Number
Brief Title
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Official Title
A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 1, 2009Actual
Primary Completion Date
May 1, 2010Actual
Completion Date
May 1, 2010Actual
First Submitted Date
Dec 2, 2009
First Submission Date that Met QC Criteria
Dec 2, 2009
First Posted Date
Dec 4, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 28, 2016
Results First Submitted that Met QC Criteria
Jan 28, 2016
Results First Posted Date
Feb 26, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 22, 2018
Last Update Posted Date
Sep 21, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.
Detailed Description
Not provided
Conditions Module
Conditions
Hypertension
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
20Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Experimental
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
1 mg → 5 mg → 12 mg → Candesartan → Pbo
Experimental
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
1 mg → Candesartan → Pbo → 24 mg → 38 mg
Experimental
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
1 mg → 5 mg → 12 mg → Pbo → Candesartan
Experimental
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-5478
Drug
In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.
1 mg → 5 mg → 12 mg → Candesartan → Pbo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With One or More Adverse Events (AEs)
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Up to 14 days after administration of last dose of study drug (up to Day 52)
Number of Participants Who Discontinued Treatment Due to an AE
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Up to 24 hours after administration of study drug
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan
Pre-dose and up to 48 hours postdose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Part I:
Is a male between 18 to 50 years of age
Is in good health
Is a non-smoker
Part II:
Is male of non-child bearing potential between 18 and 50 years of age
Has hypertension (high blood pressure)
Exclusion Criteria:
Part I and Part II:
Has a history of stroke, seizures or major neurological disorder
Has a history of cancer
Has a history of any cardiovascular disease
Is unable to refrain from the use of any prescription or non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
A Part II of this study was planned. However, since the efficacy criteria for advancing to Part II were not met in Part I, this study was considered completed with the completion of Part I. Therefore participants were not recruited for Part II.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
FG001
1 mg → 5 mg → 12 mg → Candesartan → Pbo
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
FG002
1 mg → Candesartan → Pbo → 24 mg → 38 mg
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
FG003
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
FG004
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
FG005
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
FG006
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
FG007
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
FG008
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
FG009
Candesartan → Pbo → 12 mg → 24 mg → 38 mg
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Washout 1
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Washout 2
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 3
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Washout 3
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 4
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Washout 4
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 5
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All randomized participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
BG001
1 mg → 5 mg → 12 mg → Candesartan → Pbo
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With One or More Adverse Events (AEs)
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
Posted
Number
Participants
Up to 14 days after administration of last dose of study drug (up to Day 52)
ID
Title
Description
OG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
Adverse Events Module
Frequency Threshold
5
Time Frame
14 days after administration of last dose of study drug (up to Day 52)
Description
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Eye haemorrhage
Eye disorders
MedDRA Version 13.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Belgium
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006973
Hypertension
Ancestor Terms
ID
Term
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C077793
candesartan cilexetil
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Comparator: Pbo
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Experimental
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
2 mg→Pbo → Candesartan → Pbo fed→38 mg
Experimental
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
2 mg→Candesartan→Pbo→Candesartan fed→38 mg
Experimental
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo
Experimental
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg
Experimental
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
Candesartan→Pbo → 12 mg → 24 mg→38 mg
Experimental
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Drug: MK-5478
Drug: Comparator: Candesartan cilexetil
Drug: Comparator: Pbo
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg → Candesartan → Pbo → 24 mg → 38 mg
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo
2 mg→Candesartan→Pbo→Candesartan fed→38 mg
2 mg→Pbo → Candesartan → Pbo fed→38 mg
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg
Candesartan→Pbo → 12 mg → 24 mg→38 mg
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Comparator: Candesartan cilexetil
Drug
Single dose administration of candesartan, 32 mg oral tablet
1 mg → 5 mg → 12 mg → Candesartan → Pbo
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg → Candesartan → Pbo → 24 mg → 38 mg
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo
2 mg→Candesartan→Pbo→Candesartan fed→38 mg
2 mg→Pbo → Candesartan → Pbo fed→38 mg
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg
Candesartan→Pbo → 12 mg → 24 mg→38 mg
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Atacand/Amias
Comparator: Pbo
Drug
Placebo
1 mg → 5 mg → 12 mg → Candesartan → Pbo
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg → Candesartan → Pbo → 24 mg → 38 mg
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo
2 mg→Candesartan→Pbo→Candesartan fed→38 mg
2 mg→Pbo → Candesartan → Pbo fed→38 mg
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg
Candesartan→Pbo → 12 mg → 24 mg→38 mg
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.
Baseline and 1 to 3 hours postdose
Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan
Pre-dose and up to 48 hours postdose
2 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
BG002
1 mg → Candesartan → Pbo → 24 mg → 38 mg
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
BG003
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
BG004
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
BG005
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
BG006
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
BG007
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
BG008
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
BG009
Candesartan → Pbo → 12 mg → 24 mg → 38 mg
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
BG010
Total
Total of all reporting groups
2
BG0012
BG0022
BG0032
BG0042
BG0052
BG0062
BG0072
BG0082
BG0092
BG01020
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00046.5(46 to 47)
BG00138.5(29 to 48)
BG00246.0(45 to 47)
BG00335.0(21 to 49)
BG00437.5(36 to 39)
BG00544.5(40 to 49)
BG00648.0(46 to 50)
BG00746.5(44 to 49)
BG00845.0(42 to 48)
BG00939.0(38 to 40)
BG01045.5(21 to 50)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Male
BG0002
BG0012
BG0022
BG0032
BG004
OG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
OG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
OG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
OG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
OG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
OG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
OG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
OG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
OG009
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
OG010
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
OG011
Candesartan Placebo
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
OG012
MK-5478 Placebo
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0075
OG0086
OG00915
OG0102
OG0112
OG01216
Title
Denominators
Categories
Title
Measurements
OG0005
OG0013
OG0023
OG0034
OG0044
OG0053
OG0062
OG0072
OG0081
OG0099
OG0100
OG0111
OG0126
Primary
Number of Participants Who Discontinued Treatment Due to an AE
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
Posted
Number
Participants
Up to 24 hours after administration of study drug
ID
Title
Description
OG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
OG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
OG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
OG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
OG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
OG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
OG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
OG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
OG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
OG009
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
OG010
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
OG011
Candesartan Placebo
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
OG012
MK-5478 Placebo
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan
In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
Posted
Mean
Standard Deviation
umol.hr/L
Pre-dose and up to 48 hours postdose
ID
Title
Description
OG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
OG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
OG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
OG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
OG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
OG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
OG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
OG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
OG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
OG009
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
OG010
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.236± 0.141
OG0010.494± 0.202
OG0021.87± 0.538
OG003
Secondary
Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.
Results were not analyzed because none showed a > 5% decrease in AIx.
Posted
Baseline and 1 to 3 hours postdose
ID
Title
Description
OG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
OG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
OG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
OG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
OG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
OG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
OG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
OG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
OG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
OG009
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
OG010
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan
In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
Posted
Mean
Standard Deviation
µmol/L
Pre-dose and up to 48 hours postdose
ID
Title
Description
OG000
MK-5478 1 mg
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
OG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
OG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
OG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
OG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
OG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
OG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
OG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
OG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
OG009
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
OG010
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0291± 0.012
OG0010.0573± 0.0206
OG0020.254± 0.0588
OG003
0
6
5
6
EG001
MK-5478 2 mg
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
3
6
EG002
MK-5478 5 mg
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
3
6
EG003
MK-5478 8 mg
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
4
6
EG004
MK-5478 12 mg
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
4
6
EG005
MK-5478 18 mg
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
3
6
EG006
MK-5478 24 mg
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
0
6
2
6
EG007
MK-5478 38 mg
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
0
5
2
5
EG008
MK-5478 2 mg - Fed
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
0
6
1
6
EG009
MK-5478 Placebo
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
0
16
6
16
EG010
Candesartan 32 mg
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
0
15
9
15
EG011
Candesartan 32 mg - Fed
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
0
2
0
2
EG012
Candesartan Placebo
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
0
2
1
2
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Loose stools
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Toothache
Gastrointestinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Fatigue
General disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Influenza like illness
General disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Infusion site haematoma
General disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Thirst
General disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Gastroenteritis
Infections and infestations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Pharyngitis
Infections and infestations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Alanine aminotransferase increased
Investigations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Blood glucose increased
Investigations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Creatine phosphokinase increased
Investigations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Eosinophil count increased
Investigations
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0102 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Myalgia intercostal
Musculoskeletal and connective tissue disorders
MedDRA Version 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Dizziness
Nervous system disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Dizziness postural
Nervous system disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Headache
Nervous system disorders
MedDRA Version 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected16 at risk
EG0102 events2 affected15 at risk
EG0110 events0 affected2 at risk
EG0121 events1 affected2 at risk
Muscle contractions involuntary
Nervous system disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0092 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Somnolence
Nervous system disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Facial flushing
Vascular disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Orthostatic hypotension
Vascular disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Systolic hypertension
Vascular disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected16 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
Vessel puncture site haematoma
General disorders
MedDRA Version 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected16 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected2 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.