An Efficacy and Safety Study in Children 6 to Less Than 1... | NCT02235909 | Trialant
NCT02235909
Sponsor
Arbor Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Feb 25, 2025Actual
Enrollment
377Actual
Phase
Phase 3
Conditions
Hypertension
Interventions
Azilsartan Medoxomil Low-dose
Losartan
Placebo for Azilsartan Medoxomil
Placebo for Losartan
Azilsartan Medoxomil Medium-dose (20 mg)
Azilsartan Medoxomil High-dose (40 mg)
Countries
United States
Argentina
Brazil
Bulgaria
Colombia
Hungary
Italy
Mexico
Poland
South Africa
Turkey (Türkiye)
Ukraine
Protocol Section
Identification Module
NCT ID
NCT02235909
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AR14.001
Secondary IDs
Not provided
Brief Title
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
Official Title
A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension
Acronym
Not provided
Organization
Arbor Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2025
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
Mar 30, 2015Actual
Primary Completion Date
Nov 11, 2019Actual
Completion Date
Nov 11, 2019Actual
First Submitted Date
Sep 8, 2014
First Submission Date that Met QC Criteria
Sep 9, 2014
First Posted Date
Sep 10, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 19, 2024
Results First Submitted that Met QC Criteria
Feb 5, 2025
Results First Posted Date
Feb 25, 2025Actual
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
Feb 5, 2025
Last Update Posted Date
Feb 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Arbor Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which is in the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all subjects will receive azilsartan and other antihypertensive medications (if needed). Blood pressure will be assessed throughout the study.
Detailed Description
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. This study also includes a 44-week, open-label extension Phase in which all subjects will receive azilsartan and other antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood pressure will be assessed in the clinic throughout the study, and subjects may also participate in a 24-hour ambulatory blood pressure monitoring procedure at baseline, at the end of the double-blind Phase and at the end of the open-label Phase.
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-L) that was taken in Double blind OR to be switched to placebo.
Drug: Azilsartan Medoxomil Low-dose
Withdrawal Phase: Placebo to match azilsartan medoxomil low dose (AZM-L)
Placebo Comparator
Placebo Arm in the Withdrawal Phase for subjects who were on AZM-L in double blind then randomized (1:1) to placebo for withdrawal phase
Drug: Losartan
Open Label Phase: Azilsartan Medoxomil
Experimental
Azilsartan Medoxomil 10 mg which can be titrated to higher dose(s) (up to 40 mg for subjects <50 kg or up to 80 mg for subjects ≥50 kg)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Azilsartan Medoxomil Low-dose
Drug
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Double-blind: Azilsartan Medoxomil - Low dose
Double-blind: Azilsartan Medoxomil - Medium dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Seated Diastolic Blood Pressure Between AZM and Placebo
Change in Seated Diastolic Blood Pressure from Week 6/Final visit of DB Phase to Week 8/Final Visit of the Withdrawal Phase, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
Secondary Outcomes
Measure
Description
Time Frame
Change in Trough Seated Systolic Blood Pressure
Change in Trough Seated Systolic Blood Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal Phase
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The subject has hypertension (primary or secondary) defined as clinic Seated Diastolic BP ≥95th percentile (by age, gender, and height) or ≥90th percentile (by age, gender, height) if chronic renal disease, diabetes, heart failure or hypertensive target organ damage is present
If currently treated: The subject has a documented historical diagnosis of hypertension AND a post-washout clinic Seated Diastolic BP meeting the above criteria on Day -1 (or Day 1 for subjects not participating in Ambulatory Blood Pressure Monitoring)
If currently untreated: The subject has elevated Seated Diastolic BP meeting the above criteria on 3 separate occasions before Randomization, including on Day -1 (or Day 1 for subjects not participating in Ambulatory Blood Pressure Monitoring)
The subject is male or female and aged 6 to <18 years at Baseline and weighs at least 25 kg
The subject agrees to continue their previously implemented nonpharmacological life style modifications if begun prior to Screening. Note: For subjects participating in a weight loss program, the weight maintenance
Exclusion Criteria:
The subject has a clinic Seated Diastolic BP greater than 15 mm Hg and/or Seated Diastolic BP greater than 10 mm Hg above the 99th percentile for age, gender, and height as confirmed by the average (arithmetic mean) of 3 serial clinic seated BP measurements at Screening/Visit 1
The subject has a diagnosis of malignant or accelerated hypertension
The subject is currently treated with more than 2 antihypertensive agents
The subject or parent/legal guardian is not willing for the subject's previous antihypertensive medications to be stopped
The subject has participated in the intensive, active weight-loss phase of a weight-loss program within 30 days prior to Screening/Visit 1
The subject has any of the following: severe renal impairment (eGFR <30 mL/min/1.73 m2 by the Schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in remission; or serum albumin <2.5 g/dL
The subject has a history or clinical manifestations of severe cardiovascular, hepato-biliary, gastrointestinal, endocrine-metabolic (e.g., hyperthyroidism, Cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize study integrity in the opinion of the investigator
The subject is suffering from uncorrected coarctation of the aorta, or hemodynamically significant left ventricular outflow tract obstruction due to eg, aortic valvular disease, or is likely to undergo a procedure known to affect blood pressure (eg, repair of arterial anomalies) during the course of the study
The subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value >8.5% at Screening/Visit 1
The subject has hyperkalemia as defined by the central laboratory's normal reference range or any pertinent electrolyte disorders at Screening/Visit
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
18 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Steve Caras, MD
Arbor Pharmaceuticals, LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Advanced Research Center, INC
Anaheim
California
92805
United States
Direct Helpers Research Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
If the subject was taking antihypertensive medication, the subject was required a 14-day washout. The washout coincided with the Placebo Run-in. The Run-in Period consisted of two visits: Run-in, Day-14 (Visit 2); and Run-in, Day-1 (Visit 3), which only was required for subjects participating in the Ambulatory Blood Pressure Monitoring (ABPM) procedure.
Participants who were enrolled in the study may have screen failed prior to first dosing with study drug, described above.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Active Comparator: Double Blind Phase: Losartan
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Starting at Losartan 25/50 and force titrated to 50/100 mg daily at Week 2.
There are 3 phases in this study. Double-blind, withdrawal phase, and open-label phase.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Double-blind masking in the Double Blind Phase and Withdrawal Phase.
Who Masked
ParticipantCare ProviderInvestigator
Drug: Azilsartan Medoxomil Low-dose
Withdrawal Phase: Losartan 50 mg
Active Comparator
Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
Drug: Losartan
Withdrawal Phase: Placebo to Losartan
Placebo Comparator
Placebo Arm In the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
Drug: Placebo for Losartan
Double-blind: Azilsartan Medoxomil - Medium dose
Experimental
6-week, double-blind (DB), randomized, treatment phase (DB Phase), Azilsartan medoxomil Medium-dose (AZM-M), 20 mg once daily at Week 2.
Drug: Azilsartan Medoxomil Low-dose
Drug: Placebo for Losartan
Drug: Azilsartan Medoxomil Medium-dose (20 mg)
Double-blind: Azilsartan Medoxomil - High dose (AZM-H)
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-M) that was taken in Double blind OR to be switched to placebo.
Drug: Azilsartan Medoxomil Low-dose
Drug: Azilsartan Medoxomil Medium-dose (20 mg)
Withdrawal: Azilsartan Medoxomil - High dose
Experimental
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-H) that was taken in double blind OR to be switched to placebo.
Drug: Azilsartan Medoxomil High-dose (40 mg)
Withdrawal Phase: Placebo to match azilsartan medoxomil medium dose (AZM-M)
Experimental
Placebo arm in the Withdrawal Phase for subjects who were on AZM-M in double blind then randomized (1:1) to matching placebo for withdrawal phase
Drug: Placebo for Azilsartan Medoxomil
Withdrawal Phase: Placebo to match azilsartan medoxomil high dose (AZM-H)
Experimental
Placebo arm in the Withdrawal Phase for subjects who were on AZM-H in Double blind then randomized (1:1) to matching placebo for withdrawal phase
Withdrawal Phase: Placebo to match azilsartan medoxomil low dose (AZM-L)
Cozaar
Placebo for Azilsartan Medoxomil
Drug
Withdrawal Phase: Placebo to match azilsartan medoxomil high dose (AZM-H)
Withdrawal Phase: Placebo to match azilsartan medoxomil medium dose (AZM-M)
Placebo for Losartan
Drug
Double-blind: Azilsartan Medoxomil - Medium dose
Withdrawal Phase: Placebo to Losartan
Azilsartan Medoxomil Medium-dose (20 mg)
Drug
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Double-blind: Azilsartan Medoxomil - Medium dose
Withdrawal: Azilsartan Medoxomil - Medium dose
AR14
AZM-M
Azilsartan Medoxomil High-dose (40 mg)
Drug
Azilsartan medoxomil high-dose (AZM-L) 40 mg
Double-blind: Azilsartan Medoxomil - High dose (AZM-H)
Withdrawal: Azilsartan Medoxomil - High dose
AR14
AZM-H
Change in Mean Arterial Pressure
Change in Mean Arterial Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
Hialeah
Florida
33012
United States
JDH Medical Group LLC
Miami
Florida
33125
United States
University of Miami/Jackson Memorial Hospital
Miami
Florida
33136
United States
Medical Research Center of Miami II, Inc.
Miami
Florida
33144
United States
Pioneer Clinical Research
North Miami
Florida
33162
United States
Georgia Clinical Research
Snellville
Georgia
30078
United States
Zoe Center for Pediatrics
Thomaston
Georgia
30286
United States
University of Louisville
Louisville
Kentucky
40202
United States
David M. Headley, MD PA
Port Gibson
Mississippi
39150
United States
Mount Sinai PRIME
Lake Success
New York
10029
United States
Medical University of South Carolina (MUSC)
Charleston
South Carolina
29425
United States
Memphis and Shelby County Pediatric Group
Memphis
Tennessee
38116
United States
Southeast Texas Clinical Research Center
Beaumont
Texas
77701
United States
Texas Children's Heart Center
Houston
Texas
77030
United States
Ericksen Research & Development, LLC
Clinton
Utah
84015
United States
Mid-Columbia Research
Richland
Washington
99352
United States
Hospital Italiano
Ciudad Autonoma
Buenos Aires
1181
Argentina
Hospital de Niños
Ciudad Autonoma
Buenos Aires
C1425EFD
Argentina
Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A
Placebo Arm In the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
FG005
Active Comparator: Withdrawal Phase: Losartan 50 mg
Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.
FG006
Active Comparator: WITHDRAWAL Phase: Azilsartan Medoxomil LOW-dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil low dose) that was taken in Double blind OR to be switched to placebo.
FG007
Experimental: WITHDRAWAL Azilsartan Medoxomil - Medium Dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil MEDIUM dose) that was taken in Double blind OR to be switched to placebo.
FG008
Experimental: WITHDRAWAL Azilsartan Medoxomil - High Dose
Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment ( Azilsartan medoxomil HIGH dose) that was taken in Double blind OR to be switched to placebo.
FG009
Azilsartan Medoxomil Alone
A subset of subjects taking AZM (10, 20, 40, or 80 mg) alone
FG010
AZM Plus
A subset of subjects taking AZM (10, 20, 40, or 80 mg) plus additional antihypertensives as needed
FG00053 subjects
FG00152 subjects
FG00256 subjects
FG00354 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00047 subjects
FG00152 subjects
FG00253 subjects
FG00351 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0006 subjects
FG0010 subjects
FG0023 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004103 subjects
FG00523 subjects
FG00626 subjects
FG00726 subjects
FG00825 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open Label
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG009156 subjects
FG01041 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Demographic Characteristics at Double-Blind Phase
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZM-H
Subjects who received AZM-H
BG001
AZM-M
Subjects who received AZM-M
BG002
AZM-L
Subjects who received AZM-L
BG003
Losartan
Subjects who received Losartan
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00054
BG00156
BG00252
BG00353
BG004215
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00013.5± 2.85
BG00113.4± 3.1
BG00213.4± 2.92
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00140
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Weight (kg)
Mean
Standard Deviation
kilogram
Title
Denominators
Categories
Title
Measurements
BG00068.97± 24.744
BG00166.65± 24.627
BG002
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
Change in Seated Diastolic Blood Pressure Between AZM and Placebo
Change in Seated Diastolic Blood Pressure from Week 6/Final visit of DB Phase to Week 8/Final Visit of the Withdrawal Phase, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Posted
Mean
Standard Deviation
mmHg
From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
ID
Title
Description
OG000
Pooled Placebo
Subjects who received Placebo
OG001
Pooled AZM
Subjects who received AZM
Units
Counts
Participants
OG00079
OG00177
Title
Denominators
Categories
Title
Measurements
OG0003.9± 8
OG001-1.6± 6.69
Secondary
Change in Trough Seated Systolic Blood Pressure
Change in Trough Seated Systolic Blood Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Posted
Mean
Standard Deviation
mmHg
From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal Phase
ID
Title
Description
OG000
Pooled Placebo
Subjects who received Placebo
OG001
Pooled AZM
Subjects who received AZM
Units
Counts
Participants
Secondary
Change in Mean Arterial Pressure
Change in Mean Arterial Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment
Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases.
Posted
Mean
Standard Deviation
mmHg
From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
ID
Title
Description
OG000
Pooled Placebo
Subjects who received Placebo
OG001
Pooled AZM
Subjects who received AZM
Units
Counts
Participants
Time Frame
54 weeks
Description
During the Placebo Run-In period, the pretreatment event/adverse event reported was less than the reporting threshold.
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
Placebo Run-In
Placebo run-in phase
0
289
0
289
0
289
EG001
Losartan (Double-Blind Phase)
Subjects who received Losartan (Double-Blind Phase)
0
53
2
53
6
53
EG002
AZM-L (Double-Blind Phase)
Subjects who received AZM-L (Double-Blind Phase)
0
52
1
52
5
52
EG003
AZM-M (Double-Blind Phase)
Subjects who received AZM-M (Double-Blind Phase)
0
56
1
56
6
56
EG004
AZM-H (Double-Blind Phase)
Subjects who received AZM-H (Double-Blind Phase)
0
54
0
54
5
54
EG005
Placebo (Withdrawal Phase)
Subjects who received Placebo (Withdrawal Phase)
0
103
0
103
6
103
EG006
Losartan (Withdrawal Phase)
Subjects who received Losartan (Withdrawal Phase)
0
23
0
23
0
23
EG007
AZM-L (Withdrawal Phase)
Subjects who received AZM-L (Withdrawal Phase)
0
26
1
26
4
26
EG008
AZM-M (Withdrawal Phase)
Subjects who received AZM-M (Withdrawal Phase)
0
26
0
26
0
26
EG009
AZM-H (Withdrawal Phase)
Subjects who received AZM-H (Withdrawal Phase)
0
25
0
25
0
25
EG010
Azilsartan Medoxomil Alone
Subjects who receive only AZM
0
156
7
156
11
156
EG011
Azilsartan Medoxomil PLUS
Subjects who receive AZM and any additional antihypertensive therapies