CompletedNCT02235909Updated Feb 25, 2025Results posted

An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension

A Phase 3 interventional study of Azilsartan Medoxomil Low-dose and Losartan in Hypertension, sponsored by Arbor Pharmaceuticals, Inc.. Completed at 69 sites in 12 countries. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Arbor Pharmaceuticals, Inc. (part of Azurity Pharmaceuticals) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 377
Allocation: Randomized
Ages: 6 Years to 18 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Hypertension

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Keywords

Pediatric Hypertension
High Blood Pressure
Hypertension
Pediatric
Primary Hypertension
Secondary Hypertension

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 377 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Arbor Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Browse Arbor Pharmaceuticals, Inc. studies →All Azurity Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
1. 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)
2. 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 377 participants (actual)

Study arms

Experimental
Double-blind: Azilsartan Medoxomil - Low dose
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil low-dose (AZM-L), 10 mg once daily.
Drug: Azilsartan Medoxomil Low-dose
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.
Drug: Losartan
Active comparator
Withdrawal Phase: Azilsartan medoxomil low-dose (AZM-L)
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
Placebo comparator
Withdrawal Phase: Placebo to match azilsartan medoxomil low dose (AZM-L)
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
Experimental
Open Label Phase: Azilsartan Medoxomil
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)
Drug: Azilsartan Medoxomil Low-dose
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.
Drug: Losartan
Placebo comparator
Withdrawal Phase: Placebo to Losartan
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
Experimental
Double-blind: Azilsartan Medoxomil - Medium dose
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)
Experimental
Double-blind: Azilsartan Medoxomil - High dose (AZM-H)
6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil High-dose (AZM-H), 40 mg AZM-M
Drug: Azilsartan Medoxomil High-dose (40 mg)
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 (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)
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 (AZM-H) that was taken in double blind OR to be switched to placebo.
Drug: Azilsartan Medoxomil High-dose (40 mg)
Experimental
Withdrawal Phase: Placebo to match azilsartan medoxomil medium dose (AZM-M)
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
Experimental
Withdrawal Phase: Placebo to match azilsartan medoxomil high dose (AZM-H)
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
Drug: Placebo for Azilsartan Medoxomil

Interventions

DrugAzilsartan Medoxomil Low-dose
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Also known as: AR14, AZM-L
DrugLosartan
Also known as: Cozaar
DrugPlacebo for Azilsartan Medoxomil
DrugPlacebo for Losartan
DrugAzilsartan Medoxomil Medium-dose (20 mg)
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Also known as: AR14, AZM-M
DrugAzilsartan Medoxomil High-dose (40 mg)
Azilsartan medoxomil high-dose (AZM-L) 40 mg
Also known as: AR14, AZM-H

What researchers measure

Primary outcomes

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
Time frame: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase

Secondary outcomes

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
Time frame: From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal Phase
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
Time frame: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase

Results

Posted Feb 25, 2025

Participant flow

Double-Blind Phase

Participant flow — Double-Blind Phase
Milestone	Active Comparator: Double Blind Phase: Losartan	Experimental: Double-blind: Azilsartan Medoxomil - Low Dose	Experimental: Double-blind: Azilsartan Medoxomil - Medium Dose	Experimental: Double-blind: Azilsartan Medoxomil - High Dose
Started	53	52	56	54
Completed	47	52	53	51
Not completed	6	0	3	3

Withdrawal Phase

Participant flow — Withdrawal Phase
Milestone	Placebo Comparator: Withdrawal Phase: PLACEBO	Active Comparator: Withdrawal Phase: Losartan 50 mg	Active Comparator: WITHDRAWAL Phase: Azilsartan Medoxomil LOW-dose	Experimental: WITHDRAWAL Azilsartan Medoxomil - Medium Dose	Experimental: WITHDRAWAL Azilsartan Medoxomil - High Dose
Started	103	23	26	26	25
Completed	102	22	26	24	23
Not completed	1	1	0	2	2

Open Label

Participant flow — Open Label
Milestone	Azilsartan Medoxomil Alone	AZM Plus
Started	156	41
Completed	144	40
Not completed	12	1

Outcome measures

PrimaryChange 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

Time frame:: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
Reported as:: Mean · mmHg

Change in Seated Diastolic Blood Pressure Between AZM and Placebo
mmHg	Pooled Placebo	Pooled AZM
Change in Seated Diastolic Blood Pressure Between AZM and Placebo	3.9 ± 8	-1.6 ± 6.69

SecondaryChange 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

Time frame:: From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal Phase
Reported as:: Mean · mmHg

Change in Trough Seated Systolic Blood Pressure
mmHg	Pooled Placebo	Pooled AZM
Change in Trough Seated Systolic Blood Pressure	4.4 ± 9.96	-2.3 ± 8.72

SecondaryChange 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

Time frame:: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
Reported as:: Mean · mmHg

Change in Mean Arterial Pressure
mmHg	Pooled Placebo	Pooled AZM
Change in Mean Arterial Pressure	4.1 ± 7.43	-1.8 ± 6.63

Adverse events

Collected over 54 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Run-In	0/289 (0%)	0/289 (0%)	0/289 (0%)
Losartan (Double-Blind Phase)	0/53 (0%)	2/53 (3.8%)	6/53 (11.3%)
AZM-L (Double-Blind Phase)	0/52 (0%)	1/52 (1.9%)	5/52 (9.6%)
AZM-M (Double-Blind Phase)	0/56 (0%)	1/56 (1.8%)	6/56 (10.7%)
AZM-H (Double-Blind Phase)	0/54 (0%)	0/54 (0%)	5/54 (9.3%)
Placebo (Withdrawal Phase)	0/103 (0%)	0/103 (0%)	6/103 (5.8%)
Losartan (Withdrawal Phase)	0/23 (0%)	0/23 (0%)	0/23 (0%)
AZM-L (Withdrawal Phase)	0/26 (0%)	1/26 (3.8%)	4/26 (15.4%)
AZM-M (Withdrawal Phase)	0/26 (0%)	0/26 (0%)	0/26 (0%)
AZM-H (Withdrawal Phase)	0/25 (0%)	0/25 (0%)	0/25 (0%)
Azilsartan Medoxomil Alone	0/156 (0%)	7/156 (4.5%)	11/156 (7.1%)
Azilsartan Medoxomil PLUS	0/41 (0%)	2/41 (4.9%)	32/41 (78%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Placebo Run-In	Losartan (Double-Blind Phase)	AZM-L (Double-Blind Phase)	AZM-M (Double-Blind Phase)	AZM-H (Double-Blind Phase)	Placebo (Withdrawal Phase)	Losartan (Withdrawal Phase)	AZM-L (Withdrawal Phase)	AZM-M (Withdrawal Phase)	AZM-H (Withdrawal Phase)	Azilsartan Medoxomil Alone	Azilsartan Medoxomil PLUS
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders	—	0/53	0/52	0/56	0/54	0/103	0/23	1/26	0/26	0/25	1/156	0/41
PneumoniaRespiratory, thoracic and mediastinal disorders	—	0/53	0/52	1/56	0/54	0/103	0/23	0/26	0/26	0/25	0/156	1/41
Urinary tract infectionInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	0/156	1/41
Autism spectrum disorderPsychiatric disorders	—	0/53	1/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	0/156	0/41
HypertensionVascular disorders	—	1/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	0/156	0/41
Loss of consciousnessNervous system disorders	—	1/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	0/156	0/41
VomitingGastrointestinal disorders	—	0/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	1/156	0/41
Transplant rejectionImmune system disorders	—	0/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	1/156	0/41
PeritonitisInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	1/156	0/41
Respiratory tract infection viralInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	0/23	0/26	0/26	0/25	1/156	0/41

Most frequent other events

Most frequent other events
Event	Placebo Run-In	Losartan (Double-Blind Phase)	AZM-L (Double-Blind Phase)	AZM-M (Double-Blind Phase)	AZM-H (Double-Blind Phase)	Placebo (Withdrawal Phase)	Losartan (Withdrawal Phase)	AZM-L (Withdrawal Phase)	AZM-M (Withdrawal Phase)	AZM-H (Withdrawal Phase)	Azilsartan Medoxomil Alone	Azilsartan Medoxomil PLUS
Upper respiratory tract infectionInfections and infestations	—	0/53	5/52	0/56	0/54	0/103	—	2/26	—	—	0/156	6/41
NasopharyngitisGastrointestinal disorders	—	3/53	0/52	3/56	2/54	0/103	—	0/26	—	—	0/156	5/41
HeadacheNervous system disorders	—	3/53	0/52	3/56	3/54	6/103	—	2/26	—	—	11/156	0/41
DiarrhoeaGastrointestinal disorders	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
GastroenteritisInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
InfluenzaInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
PharyngotonsillitisInfections and infestations	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
MyalgiaMusculoskeletal and connective tissue disorders	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41
HypertensionVascular disorders	—	0/53	0/52	0/56	0/54	0/103	—	0/26	—	—	0/156	3/41

Baseline characteristics

Demographic Characteristics at Double-Blind Phase

Age, Continuous
Age, Continuous(years)	AZM-H	AZM-M	AZM-L	Losartan	Total
Mean	13.5 ± 2.85	13.4 ± 3.1	13.4 ± 2.92	13.2 ± 3.18	13.4 ± 3

Sex: Female, Male
Sex: Female, Male(Participants)	AZM-H	AZM-M	AZM-L	Losartan	Total
Female	25	40	28	25	118
Male	29	16	24	28	97

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AZM-H	AZM-M	AZM-L	Losartan	Total
American Indian or Alaska Native	1	0	1	1	3
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	15	14	13	13	55
White	37	42	38	38	155
More than one race	1	0	0	1	2
Unknown or Not Reported	0	0	0	0	0

Weight (kg)
Weight (kg)(kilogram)	AZM-H	AZM-M	AZM-L	Losartan	Total
Mean	68.97 ± 24.744	66.65 ± 24.627	72.53 ± 28.556	69.00 ± 26.235	69.23 ± 25.952

Study locations

69 sites

Advanced Research Center, INC
Anaheim, California 92805, United States
Direct Helpers Research Center
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
Santa Fe, S3000EPV, Argentina
Clínica Nefrokids Ltda
Curitiba, 80240-060, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, 90620-001, Brazil
Fundação José Luiz Egydio Setúbal
São Paulo, 01227-200, Brazil
Hospital Samaritano
São Paulo, 01232-010, Brazil
Eurolatino Pesquisas Médicas Ltda.
Uberlândia, 38411-186, Brazil
SHATPPD-Ruse EOOD
Rousse, 7002, Bulgaria
Fundacion Oftalmologica de Santander - FOSCAL
Bucaramanga, Colombia
Fundacion Valle del Lili
Cali, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, Colombia
Hospital Pablo Tobón Uribe
Medellín, Colombia
Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
Medellín, Colombia
Principal SMO Kft.
Baja, 6500, Hungary
Svabhegy Plusz Gyermekegeszsegugyi Kozpont
Budapest, 1037, Hungary
Szent Lukacs Korhaz Dombovar
Dombóvár, 7200, Hungary
Prehospital Med Kft.
Miskolc, 3526, Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Kozp.
Szeged, 6720, Hungary
Ospedale Pediatrico Giovanni XXIII
Bari, 70125, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
A.R.N.A.S. Ospedale Civico e Benfratelli, G. Cristina e M.Ascoli
Palermo, Italy
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Hospital General de Mexico
Mexico City, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, 6400, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, 58260, Mexico
SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
Bialystok, 15-274, Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30-663, Poland
NZOZ TRI-medica
Lodz, 93-338, Poland
Praktyka Lekarzy Rodzinnych R.Jadach, M.Domanski NZOZ
Wroclaw, 50-072, Poland
LCS Clinical Research Unit
Johannesburg, Gauteng 2021, South Africa
Soweto Clinical Trial Centre
Soweto, Gauteng 1818, South Africa
Netcare St. Anne's Hospital
Pietermaritzburg, KwaZulu-Natal 3201, South Africa
Groote Schuur Hospital E13 Renal Unit
Cape Town, Western Cape 7925, South Africa
Clinical Projects Research SA (PTY) LTD
Worcester, Western Cape 6850, South Africa
CRISMO Bertha Gxowa Research Centre
Germiston, South Africa
Cukurova University Medical Faculty
Adana, 01330, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Dokuz Eylul University Medicine Faculty
Izmir, 35100, Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, 38039, Turkey (Türkiye)
Celal Bayar University Medical Faculty
Manisa, 45040, Turkey (Türkiye)
CMI Chernivtsi City Children Clinical Hospital
Chernivtsi, Ukraine
Regional Children CH Cardiology Department Kharkiv NMU
Kharkiv, Ukraine
SI National Research Center of Radiation Medicine of NAMSU
Kyiv, Ukraine
USPC of ES EO&T Transplantation of MHU
Kyiv, Ukraine
HSEI of Ukraine UMSA
Poltava, Ukraine
SSU Division MU Ch of pediatrics
Sumy, Ukraine
Vynnitsa Regional Children CH pediatric department № 1 M.I. Pyrogov NMU
Vinnytsia, Ukraine
CI Zaporizhzhia City Multibranch Children Hospital #5
Zaporizhzhya, Ukraine
CI Zaporizhzhia Regional Clinical Children Hospital of ZRC
Zaporizhzhya, Ukraine

References and documents

Study documents

Study protocol · Dec 12, 2018
Statistical analysis plan · Jan 13, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Nov 2019, 55 months.

Results were first posted in Feb 2025, 5 years 3 months after primary completion.

Of 178 industry-sponsored phase 3 interventional studies under Hypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 55 months is above that.

Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 13 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 8, 2014
First posted: Sep 10, 2014
StartActual: Mar 30, 2015
Primary completionActual: Nov 11, 2019
CompletionActual: Nov 11, 2019
Results first posted: Feb 25, 2025
Last update: Feb 25, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02235909
Lead sponsor: Arbor Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Sep 10, 2014
Start date: Mar 30, 2015
Primary completion: Nov 11, 2019
Completion: Nov 11, 2019
Results posted: Feb 25, 2025
Last update: Feb 25, 2025

Study contacts

Steve Caras, MD

study director · Arbor Pharmaceuticals, LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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