Phase 3
N=215
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02235909 ↗Enrolled (actual)
215
Serious AEs
1.6%
Results posted
Feb 2025
Primary outcome: Primary: Change in Seated Diastolic Blood Pressure Between AZM and Placebo — 3.9; -1.6 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azilsartan Medoxomil Low-dose (Drug); Losartan (Drug); Placebo for Azilsartan Medoxomil (Drug); Placebo for Losartan (Drug); Azilsartan Medoxomil Medium-dose (20 mg) (Drug); Azilsartan Medoxomil High-dose (40 mg) (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Arbor Pharmaceuticals, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Seated Diastolic Blood Pressure Between AZM and Placebo |
3.9; -1.6 | — |
| SECONDARY Change in Trough Seated Systolic Blood Pressure |
4.4; -2.3 | — |
| SECONDARY Change in Mean Arterial Pressure |
4.1; -1.8 | — |
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.
Eligibility 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
- 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)
- 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 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
Data sourced from ClinicalTrials.gov (NCT02235909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.