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COMPLETED Phase 3

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

NCT02235909 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Losartan
  • DRUG Azilsartan Medoxomil Low-dose
  • DRUG Placebo for Azilsartan Medoxomil
  • DRUG Placebo for Losartan
  • DRUG Azilsartan Medoxomil Medium-dose (20 mg)

Study Locations (20)

Florida

  • Direct Helpers Research Center — Hialeah
  • JDH Medical Group LLC — Miami
  • University of Miami/Jackson Memorial Hospital — Miami
  • Medical Research Center of Miami II, Inc. — Miami
  • Pioneer Clinical Research — North Miami

Georgia

  • Georgia Clinical Research — Snellville
  • Zoe Center for Pediatrics — Thomaston

Texas

  • Southeast Texas Clinical Research Center — Beaumont
  • Texas Children's Heart Center — Houston

Buenos Aires

  • Hospital Italiano — Ciudad Autonoma
  • Hospital de Niños — Ciudad Autonoma

California

  • Advanced Research Center, INC — Anaheim

Kentucky

  • University of Louisville — Louisville

Mississippi

  • David M. Headley, MD PA — Port Gibson

New York

  • Mount Sinai PRIME — Lake Success

Trial Details

FieldValue
Enrollment Target 377 participants
Start Date 2015-03-30
Est. Completion 2019-11-11
Phase Phase 3

Sponsor

Arbor Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02235909

The ClinicalTrials.gov registry entry for NCT02235909 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 377 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arbor Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 5 interventions — of which Losartan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02235909 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Georgia, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02235909 about?

NCT02235909 is a clinical study titled "An Efficacy and Safety Study 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-b...

What is the current status of trial NCT02235909?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 377 participants. The study started on 2015-03-30. Estimated completion is 2019-11-11.

What conditions does trial NCT02235909 study?

This clinical trial studies the following conditions: Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02235909?

The interventions under investigation include: Losartan (DRUG), Azilsartan Medoxomil Low-dose (DRUG), Placebo for Azilsartan Medoxomil (DRUG), Placebo for Losartan (DRUG), Azilsartan Medoxomil Medium-dose (20 mg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02235909?

This trial is sponsored by Arbor Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02235909 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Kentucky, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial