HypertensionPhase 3NCT02235909
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
A Phase 3 study testing Azilsartan Medoxomil Low-dose, Losartan and Azilsartan Medoxomil Medium-dose (20 mg) in people with Hypertension, run by Arbor Pharmaceuticals, Inc. at 69 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan Medoxomil Low-dose, Losartan and Azilsartan Medoxomil Medium-dose (20 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 69 sitesin 12 countries
- Study dates
- 30 Mar 2015to 11 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
69 sites in 12 countries.
69 sites in 12 countries
United States17 sites
Advanced Research Center, INC
Anaheim, California, 92805
Southeast Texas Clinical Research Center
Beaumont, Texas, 77701
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Ericksen Research & Development, LLC
Clinton, Utah, 84015
Direct Helpers Research Center
Hialeah, Florida, 33012
Texas Children's Heart Center
Houston, Texas, 77030
Mount Sinai PRIME
Lake Success, New York, 10029
University of Louisville
Louisville, Kentucky, 40202
Memphis and Shelby County Pediatric Group
Memphis, Tennessee, 38116
JDH Medical Group LLC
Miami, Florida, 33125
University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136
Medical Research Center of Miami II, Inc.
Miami, Florida, 33144
Pioneer Clinical Research
North Miami, Florida, 33162
David M. Headley, MD PA
Port Gibson, Mississippi, 39150
Mid-Columbia Research
Richland, Washington, 99352
Georgia Clinical Research
Snellville, Georgia, 30078
Zoe Center for Pediatrics
Thomaston, Georgia, 30286
Ukraine9 sites
CMI Chernivtsi City Children Clinical Hospital
Chernivtsi
Regional Children CH Cardiology Department Kharkiv NMU
Kharkiv
SI National Research Center of Radiation Medicine of NAMSU
Kyiv
USPC of ES EO&T Transplantation of MHU
Kyiv
HSEI of Ukraine UMSA
Poltava
SSU Division MU Ch of pediatrics
Sumy
Vynnitsa Regional Children CH pediatric department № 1 M.I. Pyrogov NMU
Vinnytsia
CI Zaporizhzhia City Multibranch Children Hospital #5
Zaporizhzhya
CI Zaporizhzhia Regional Clinical Children Hospital of ZRC
Zaporizhzhya
Brazil6 sites
Clínica Nefrokids Ltda
Curitiba, 80240-060
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, 90620-001
Fundação José Luiz Egydio Setúbal
São Paulo, 01227-200
Hospital Samaritano
São Paulo, 01232-010
Eurolatino Pesquisas Médicas Ltda.
Uberlândia, 38411-186
South Africa6 sites
Groote Schuur Hospital E13 Renal Unit
Cape Town, Western Cape, 7925
CRISMO Bertha Gxowa Research Centre
Germiston
LCS Clinical Research Unit
Johannesburg, Gauteng, 2021
Netcare St. Anne's Hospital
Pietermaritzburg, KwaZulu-Natal, 3201
Soweto Clinical Trial Centre
Soweto, Gauteng, 1818
Clinical Projects Research SA (PTY) LTD
Worcester, Western Cape, 6850
Turkey (Türkiye)6 sites
Cukurova University Medical Faculty
Adana, 01330
Gazi University Medical Faculty
Ankara, 06500
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
Dokuz Eylul University Medicine Faculty
Izmir, 35100
Erciyes University Medical Faculty
Kayseri, 38039
Celal Bayar University Medical Faculty
Manisa, 45040
Colombia5 sites
Fundacion Oftalmologica de Santander - FOSCAL
Bucaramanga
Fundacion Valle del Lili
Cali
Fundacion Hospitalaria San Vicente de Paul
Medellín
Hospital Pablo Tobón Uribe
Medellín
Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
Medellín
Hungary5 sites
Principal SMO Kft.
Baja, 6500
Svabhegy Plusz Gyermekegeszsegugyi Kozpont
Budapest, 1037
Szent Lukacs Korhaz Dombovar
Dombóvár, 7200
Prehospital Med Kft.
Miskolc, 3526
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Kozp.
Szeged, 6720
Mexico4 sites
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Hospital General de Mexico
Mexico City
Accelerium S. de R.L. de C.V.
Monterrey, 6400
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, 58260
Poland4 sites
SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
Bialystok, 15-274
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30-663
NZOZ TRI-medica
Lodz, 93-338
Praktyka Lekarzy Rodzinnych R.Jadach, M.Domanski NZOZ
Wroclaw, 50-072
Argentina3 sites
Hospital Italiano
Ciudad Autonoma, Buenos Aires, 1181
Hospital de Niños
Ciudad Autonoma, Buenos Aires, C1425EFD
Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A
Santa Fe, S3000EPV
Italy3 sites
Ospedale Pediatrico Giovanni XXIII
Bari, 70125
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
A.R.N.A.S. Ospedale Civico e Benfratelli, G. Cristina e M.Ascoli
Palermo
About this study
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
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
- Hypertension
- Being tested
- Azilsartan Medoxomil Low-dose, Losartan, Placebo for Azilsartan Medoxomil, Placebo for Losartan, Azilsartan Medoxomil Medium-dose (20 mg)
- Keywords
- Pediatric Hypertension, High Blood Pressure, Hypertension, Pediatric, Primary Hypertension, Secondary Hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan Medoxomil Low-doseDrug
Also called AR14, AZM-L
Azilsartan medoxomil low-dose (AZM-L) 10 mg
LosartanDrug
Also called Cozaar
Placebo for Azilsartan MedoxomilDrug
Placebo for LosartanDrug
Azilsartan Medoxomil Medium-dose (20 mg)Drug
Also called AR14, AZM-M
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Azilsartan Medoxomil High-dose (40 mg)Drug
Also called AR14, AZM-H
Azilsartan medoxomil high-dose (AZM-L) 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Double-blind: Azilsartan Medoxomil - Low dose | Experimental | 6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil low-dose (AZM-L), 10 mg once daily. Receives: Drug: Azilsartan Medoxomil Low-dose |
| Double blind phase: Losartan | Active comparator | 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. Receives: Drug: Losartan |
| Withdrawal Phase: Azilsartan medoxomil low-dose (AZM-L) | Active comparator | 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. Receives: 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 Receives: 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) Receives: 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. Receives: 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. Receives: 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. Receives: 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 | 6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil High-dose (AZM-H), 40 mg AZM-M Receives: Drug: Azilsartan Medoxomil High-dose (40 mg) |
| Withdrawal: Azilsartan Medoxomil - Medium dose | Experimental | 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. Receives: 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. Receives: 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 Receives: 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 Receives: Drug: Placebo for Azilsartan Medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
Secondary outcomes (2)
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
Measured: 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
Measured: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start30 Mar 2015
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 3 phases in this study. Double-blind, withdrawal phase, and open-label phase.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Caras, MD, Study director, Arbor Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235909
- Sponsor's protocol ID
- AR14.001
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2014
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02235909
- Acronym / sponsor ID
- AR14.001
- Conditions
- Hypertension
- Keywords
- Pediatric Hypertension, High Blood Pressure, Hypertension, Pediatric, Primary Hypertension, Secondary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 13
- Model description
- There are 3 phases in this study. Double-blind, withdrawal phase, and open-label phase.
| Arm | Type | Receives |
|---|---|---|
| Double-blind: Azilsartan Medoxomil - Low dose | Experimental | Drug: Azilsartan Medoxomil Low-dose6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil low-dose (AZM-L), 10 mg once daily. |
| Double blind phase: Losartan | Active comparator | Drug: Losartan6-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. |
| Withdrawal Phase: Azilsartan medoxomil low-dose (AZM-L) | Active comparator | Drug: Azilsartan Medoxomil Low-doseExperimental 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. |
| Withdrawal Phase: Placebo to match azilsartan medoxomil low dose (AZM-L) | Placebo comparator | Drug: LosartanPlacebo Arm in the Withdrawal Phase for subjects who were on AZM-L in double blind then randomized (1:1) to placebo for withdrawal phase |
| Open Label Phase: Azilsartan Medoxomil | Experimental | Drug: Azilsartan Medoxomil Low-doseAzilsartan 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) |
| Withdrawal Phase: Losartan 50 mg | Active comparator | Drug: LosartanWithdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo. |
| Withdrawal Phase: Placebo to Losartan | Placebo comparator | Drug: Placebo for LosartanPlacebo 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. |
| Double-blind: Azilsartan Medoxomil - Medium dose | Experimental | Drug: Azilsartan Medoxomil Low-dose, Drug: Placebo for Losartan, Drug: Azilsartan Medoxomil Medium-dose (20 mg)6-week, double-blind (DB), randomized, treatment phase (DB Phase), Azilsartan medoxomil Medium-dose (AZM-M), 20 mg once daily at Week 2. |
| Double-blind: Azilsartan Medoxomil - High dose (AZM-H) | Experimental | Drug: Azilsartan Medoxomil High-dose (40 mg)6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil High-dose (AZM-H), 40 mg AZM-M |
| Withdrawal: Azilsartan Medoxomil - Medium dose | Experimental | Drug: Azilsartan Medoxomil Low-dose, Drug: Azilsartan Medoxomil Medium-dose (20 mg)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. |
| Withdrawal: Azilsartan Medoxomil - High dose | Experimental | Drug: Azilsartan Medoxomil High-dose (40 mg)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. |
| Withdrawal Phase: Placebo to match azilsartan medoxomil medium dose (AZM-M) | Experimental | Drug: Placebo for Azilsartan MedoxomilPlacebo 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 |
| Withdrawal Phase: Placebo to match azilsartan medoxomil high dose (AZM-H) | Experimental | Drug: Placebo for Azilsartan MedoxomilPlacebo 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilsartan Medoxomil Low-doseAlso: AR14, AZM-LAzilsartan medoxomil low-dose (AZM-L) 10 mg | Drug | Double-blind: Azilsartan Medoxomil - Low dose, Double-blind: Azilsartan Medoxomil - Medium dose, Open Label Phase: Azilsartan Medoxomil, Withdrawal Phase: Azilsartan medoxomil low-dose (AZM-L), Withdrawal: Azilsartan Medoxomil - Medium dose |
| LosartanAlso: Cozaar | Drug | Double blind phase: Losartan, Withdrawal Phase: Losartan 50 mg, Withdrawal Phase: Placebo to match azilsartan medoxomil low dose (AZM-L) |
| 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)Also: AR14, AZM-MAzilsartan medoxomil medium-dose (AZM-M) 20 mg | Drug | Double-blind: Azilsartan Medoxomil - Medium dose, Withdrawal: Azilsartan Medoxomil - Medium dose |
| Azilsartan Medoxomil High-dose (40 mg)Also: AR14, AZM-HAzilsartan medoxomil high-dose (AZM-L) 40 mg | Drug | Double-blind: Azilsartan Medoxomil - High dose (AZM-H), Withdrawal: Azilsartan Medoxomil - High dose |
Primary outcome
Change in Seated Diastolic Blood Pressure Between AZM and Placebo
Time frame: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase
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
2 secondary outcomes
Change in Trough Seated Systolic Blood Pressure
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
Time frame: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Caras, MD study director
Arbor Pharmaceuticals, LLC
69 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azilsartan Medoxomil Low-dose, Losartan and Azilsartan Medoxomil Medium-dose (20 mg) in people with Hypertension, run by Arbor Pharmaceuticals, Inc. at 69 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Ukraine, Brazil, South Africa, Turkey (Türkiye) and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seated Diastolic Blood Pressure Between AZM and Placebo (time frame: From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.