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Trial record 2 of 9 for:    azilsartan hypertension children

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

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ClinicalTrials.gov Identifier: NCT02235909
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Arbor Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan Medoxomil Drug: Losartan Drug: Placebo for Azilsartan Medoxomil Drug: Placebo for Losartan Drug: antihypertension medication Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are 3 phases in this study. Double-blind, withdrawal phase, and open-label phase.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind masking in the Double Blind Phase and Withdrawal Phase.
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : September 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double blind phase: Azilsartan Medoxomil
Double blind phase; Randomized 1:1:1:1. Once a day dosing. Azilsartan medoxomil at 10 mg, or 20 mg, or 40 mg force-titrated to 80 mg
Drug: Azilsartan Medoxomil
Other Names:
  • AZM
  • AR14

Active Comparator: Double blind phase: Losartan 25 or 50 mg
Double blind phase: Double blind phase; Randomized 1:1:1:1. Once a day dosing
Drug: Losartan
Other Name: Cozaar

Active Comparator: Withdrawal Phase: Azilsartan medoxomil dose taken in Double blind phase
Experimental 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: Azilsartan Medoxomil
Other Names:
  • AZM
  • AR14

Placebo Comparator: Withdrawal Phase: Placebo to match azilsartan medoxomil
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 Azilsartan Medoxomil
Other Name: sugar pill

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
Other Names:
  • AZM
  • AR14

Open Label Phase: "Other"
Additional antihypertension medication, as needed. Name and dose as determined by PI
Drug: Azilsartan Medoxomil
Other Names:
  • AZM
  • AR14

Drug: antihypertension medication
If add-on therapy is needed, the type of medication (eg a calcium channel blocker, such as amlodipine, a diuretic, such as hydrochlorothiazide, or a beta-blocker such as metoprolol) added will be determined per the investigator's clinical judgment.". These are not predefined.

Active Comparator: Withdrawal Phase: Losartan 25 or 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 Name: Cozaar

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 Name: sugar pill




Primary Outcome Measures :
  1. Change in Blood Pressure [ Time Frame: Double-Blind and Withdrawal Phase ]
    Change from Week 6/Final Visit of the double-blindPhase to Week 8/Final Visit of the WD Phase in trough clinic seated diastolic blood pressure between azilsartan medoxomil and placebo


Secondary Outcome Measures :
  1. Change in blood Pressure relative to the comparator [ Time Frame: Double Blind and Withdrawal Phase ]
    Change from Week 6/Final Visit of the double-blind Phase to Week 8/Final Visit of the withdrawal phase in trough clinic seated systolic blood pressure and mean arterial pressure (MAP) between azilsartan medoxomil and placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235909


Locations
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Sponsors and Collaborators
Arbor Pharmaceuticals, Inc.
Investigators
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Study Director: steve Caras, MD Arbor Pharmaceuticals, LLC
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Responsible Party: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02235909    
Other Study ID Numbers: AR14.001
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arbor Pharmaceuticals, Inc.:
Pediatric Hypertension
High Blood Pressure
Hypertension
Pediatric
Primary Hypertension
Secondary Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Azilsartan medoxomil
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action