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

February 5, 2025 updated by: Arbor Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
377

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Santa Fe, Argentina, S3000EPV
        • Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A
    • Buenos Aires
      • Ciudad Autonoma, Buenos Aires, Argentina, 1181
        • Hospital Italiano
      • Ciudad Autonoma, Buenos Aires, Argentina, C1425EFD
        • Hospital de Niños
  • Brazil
      • Curitiba, Brazil, 80240-060
        • Clínica Nefrokids Ltda
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brazil, 90620-001
        • Instituto de Cardiologia do Rio Grande do Sul
      • São Paulo, Brazil, 01232-010
        • Hospital Samaritano
      • São Paulo, Brazil, 01227-200
        • Fundacao Jose Luiz Egydio Setubal
      • Uberlândia, Brazil, 38411-186
        • Eurolatino Pesquisas Médicas Ltda.
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • SHATPPD-Ruse EOOD
  • Colombia
      • Bucaramanga, Colombia
        • Fundacion Oftalmologica de Santander - FOSCAL
      • Cali, Colombia
        • Fundacion Valle del Lili
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
      • Medellin, Colombia
        • Fundación Hospitalaria San Vicente de Paul
      • Medellin, Colombia
        • Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
  • Hungary
      • Baja, Hungary, 6500
        • Principal SMO Kft.
      • Budapest, Hungary, 1037
        • Svabhegy Plusz Gyermekegeszsegugyi Kozpont
      • Dombovar, Hungary, 7200
        • Szent Lukacs Korhaz Dombovar
      • Miskolc, Hungary, 3526
        • Prehospital Med Kft.
      • Szeged, Hungary, 6720
        • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Kozp.
  • Italy
      • Bari, Italy, 70125
        • Ospedale Pediatrico Giovanni XXIII
      • Milano, Italy, 20122
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Palermo, Italy
        • A.R.N.A.S. Ospedale Civico e Benfratelli, G. Cristina e M.Ascoli
  • Mexico
      • Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
      • Mexico City, Mexico
        • Hospital General de Mexico
      • Monterrey, Mexico, 6400
        • Accelerium S. de R.L. de C.V.
      • Morelia, Mexico, 58260
        • Centro de Investigación Clínica Chapultepec S.A. de C.V.
  • Poland
      • Bialystok, Poland, 15-274
        • SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
      • Krakow, Poland, 30-663
        • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Lodz, Poland, 93-338
        • NZOZ TRI-medica
      • Wroclaw, Poland, 50-072
        • Praktyka Lekarzy Rodzinnych R.Jadach, M.Domanski NZOZ
  • South Africa
      • Germiston, South Africa
        • CRISMO Bertha Gxowa Research Centre
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2021
        • LCS Clinical Research Unit
      • Soweto, Gauteng, South Africa, 1818
        • Soweto Clinical Trial Centre
    • KwaZulu-Natal
      • Pietermaritzburg, KwaZulu-Natal, South Africa, 3201
        • Netcare St. Anne's Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital E13 Renal Unit
      • Worcester, Western Cape, South Africa, 6850
        • Clinical Projects Research SA (PTY) LTD
  • Turkey
      • Adana, Turkey, 01330
        • Cukurova University Medical Faculty
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul Medical Faculty
      • Izmir, Turkey, 35100
        • Dokuz Eylul University Medicine Faculty
      • Kayseri, Turkey, 38039
        • Erciyes University Medical Faculty
      • Manisa, Turkey, 45040
        • Celal Bayar University Medical Faculty
  • Ukraine
      • Chernivtsi, Ukraine
        • CMI Chernivtsi City Children Clinical Hospital
      • Kharkiv, Ukraine
        • Regional Children CH Cardiology Department Kharkiv NMU
      • Kyiv, Ukraine
        • SI National Research Center of Radiation Medicine of NAMSU
      • Kyiv, Ukraine
        • USPC of ES EO&T Transplantation of MHU
      • Poltava, Ukraine
        • HSEI of Ukraine UMSA
      • Sumy, Ukraine
        • SSU Division MU Ch of pediatrics
      • Vinnytsia, Ukraine
        • Vynnitsa Regional Children CH pediatric department № 1 M.I. Pyrogov NMU
      • Zaporizhzhia, Ukraine
        • CI Zaporizhzhia City Multibranch Children Hospital #5
      • Zaporizhzhia, Ukraine
        • CI Zaporizhzhia Regional Clinical Children Hospital of ZRC
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc
    • Florida
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Miami, Florida, United States, 33125
        • JDH Medical Group LLC
      • Miami, Florida, United States, 33136
        • University of Miami/Jackson Memorial Hospital
      • Miami, Florida, United States, 33144
        • Medical Research Center of Miami II, Inc.
      • North Miami, Florida, United States, 33162
        • Pioneer Clinical Research
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Georgia Clinical Research
      • Thomaston, Georgia, United States, 30286
        • Zoe Center for Pediatrics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • David M. Headley, MD PA
    • New York
      • Lake Success, New York, United States, 10029
        • Mount Sinai PRIME
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Memphis, Tennessee, United States, 38116
        • Memphis and Shelby County Pediatric Group
    • Texas
      • Beaumont, Texas, United States, 77701
        • Southeast Texas Clinical Research Center
      • Houston, Texas, United States, 77030
        • Texas Children's Heart Center
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development, LLC
    • Washington
      • Richland, Washington, United States, 99352
        • Mid-Columbia Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Other Names:
  • AR14
  • AZM-L
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
Other Names:
  • sugar pill
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
Other Names:
  • Cozaar
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
Other Names:
  • Cozaar
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: Placebo for Losartan
Other Names:
  • sugar pill
Drug: Azilsartan Medoxomil Low-dose
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Other Names:
  • AR14
  • AZM-L
Drug: Azilsartan Medoxomil Medium-dose (20 mg)
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Other Names:
  • AR14
  • AZM-M
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
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Other Names:
  • AR14
  • AZM-L
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
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Other Names:
  • AR14
  • AZM-L
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
Other Names:
  • Cozaar
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)
Azilsartan medoxomil high-dose (AZM-L) 40 mg
Other Names:
  • AR14
  • AZM-H
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
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Other Names:
  • AR14
  • AZM-L
Drug: Azilsartan Medoxomil Medium-dose (20 mg)
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Other Names:
  • AR14
  • AZM-M
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)
Azilsartan medoxomil high-dose (AZM-L) 40 mg
Other Names:
  • AR14
  • AZM-H
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
Other Names:
  • sugar pill
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
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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
Change in Mean Arterial Pressure
Time Frame: From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arbor Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Steve Caras, MD, Arbor Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AR14.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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