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NCT02235909 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
A Phase 3 study of Hypertension, sponsored by Arbor Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 377
- Enrollment target
- 20
- Study locations
NCT02235909 is a Phase 3 study of Hypertension that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 377 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT02235909, a Phase 3 study of Hypertension, has completed, sponsored by Arbor Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 377 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2019-11-11 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 377 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (89% lower). The listed sponsor is Arbor Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
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.
NCT02235909 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Georgia, Texas.
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.
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).
Who is sponsoring clinical trial NCT02235909?
This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
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