Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Hypertension, sponsored by Arbor Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT02235909 record still lists
NCT02235909 is an interventional study that assigns participants to a tested intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (89% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02235909's enrollment target sits among peer trials
377 153rd of 470 higher than 318 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
RECRUITING · Phase 3
-
Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
RECRUITING · Phase 3
-
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
RECRUITING · Phase 3
-
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
RECRUITING · Phase 3
-
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
RECRUITING · Phase 3
-
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07024784 · 377 participants · Phase 2
A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies
- NCT04254185 · 378 participants · NA
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
- NCT06616584 · 378 participants · Phase 2
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
- NCT03102125 · 376 participants · Phase 4
Allograft Dysfunction in Heart Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI