Trial · NCT02235909
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
NCT02235909, Phase 3, Completed, Arbor Pharmaceuticals, Inc.; results first posted 2025-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension. Trials, record NCT02235909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02235909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
- NCT number
- NCT02235909
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Conditions
- Hypertension
- Interventions
- Azilsartan Medoxomil Low-dose, Losartan, Placebo for Azilsartan Medoxomil, Placebo for Losartan, Azilsartan Medoxomil Medium-dose (20 mg), Azilsartan Medoxomil High-dose (40 mg)
- First posted
- 2014-09-10
- Last updated
- 2025-02-25
- Results first posted
- 2025-02-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Seated Diastolic Blood Pressure Between AZM and Placebo | From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase | 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 |
| Secondary | Change in Trough Seated Systolic Blood Pressure | From Week 6/Final Visit of the Double-Blind Phase to Week 8/Final Visit of the Withdrawal Phase | Change in Trough Seated Systolic Blood Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment |
| Secondary | Change in Mean Arterial Pressure | From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase | Change in Mean Arterial Pressure from Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase Between AZM and Placebo, analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Seated Diastolic Blood Pressure Between AZM and Placebo | From Week 6/Final Visit of DB Phase to Week 8/Final Visit of Withdrawal Phase | Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases. | mmHg | MEAN |
| SECONDARY | Change in Trough Seated Systolic Blood Pressure | From Week 6/Final Visit of the Double-Blind 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. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases. | mmHg | MEAN |
| SECONDARY | Change in Mean Arterial Pressure | From Week 6 of the Double-Blind Phase to Week 8 of the Withdrawal Phase | Analysis of study subjects randomized to receiving placebo at Week 6 of treatment versus those who remained on treatment. The data was pooled for participants who were randomized to receive placebo from Week 6 and then pooled for participants who remained receiving AZM treatment from Week 6 to compare the difference in outcome between those who remained on AZM vs. those who changed to placebo. The placebo arms were pooled and the AZM arms were pooled during the DB and Withdrawal phases. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Seated Diastolic Blood Pressure Between AZM and Placebo | Pooled Placebo | 3.9 | Standard Deviation 8 | mmHg | |
| Change in Seated Diastolic Blood Pressure Between AZM and Placebo | Pooled AZM | -1.6 | Standard Deviation 6.69 | mmHg | |
| Change in Trough Seated Systolic Blood Pressure | Pooled Placebo | 4.4 | Standard Deviation 9.96 | mmHg | |
| Change in Trough Seated Systolic Blood Pressure | Pooled AZM | -2.3 | Standard Deviation 8.72 | mmHg | |
| Change in Mean Arterial Pressure | Pooled Placebo | 4.1 | Standard Deviation 7.43 | mmHg | |
| Change in Mean Arterial Pressure | Pooled AZM | -1.8 | Standard Deviation 6.63 | mmHg |
Source ClinicalTrials.gov
Participant flow99
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase | STARTED | Active Comparator: Double Blind Phase: Losartan | 53 | |
| Double-Blind Phase | STARTED | Experimental: Double-blind: Azilsartan Medoxomil - Low Dose | 52 | |
| Double-Blind Phase | STARTED | Experimental: Double-blind: Azilsartan Medoxomil - Medium Dose | 56 | |
| Double-Blind Phase | STARTED | Experimental: Double-blind: Azilsartan Medoxomil - High Dose | 54 | |
| Double-Blind Phase | STARTED | Placebo Comparator: Withdrawal Phase: PLACEBO | 0 | |
| Double-Blind Phase | STARTED | Active Comparator: Withdrawal Phase: Losartan 50 mg | 0 | |
| Double-Blind Phase | STARTED | Active Comparator: WITHDRAWAL Phase: Azilsartan Medoxomil LOW-dose | 0 | |
| Double-Blind Phase | STARTED | Experimental: WITHDRAWAL Azilsartan Medoxomil - Medium Dose | 0 | |
| Double-Blind Phase | STARTED | Experimental: WITHDRAWAL Azilsartan Medoxomil - High Dose | 0 | |
| Double-Blind Phase | STARTED | Azilsartan Medoxomil Alone | 0 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 participant flowAdverse events264
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Gastrointestinal disorders | Placebo Run-In | 289 | ||
| other | Nasopharyngitis | Gastrointestinal disorders | Losartan (Double-Blind Phase) | 3 | 53 | |
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-L (Double-Blind Phase) | 0 | 52 | |
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-M (Double-Blind Phase) | 3 | 56 | |
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-H (Double-Blind Phase) | 2 | 54 | |
| other | Nasopharyngitis | Gastrointestinal disorders | Placebo (Withdrawal Phase) | 0 | 103 | |
| other | Nasopharyngitis | Gastrointestinal disorders | Losartan (Withdrawal Phase) | 23 | ||
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-L (Withdrawal Phase) | 0 | 26 | |
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-M (Withdrawal Phase) | 26 | ||
| other | Nasopharyngitis | Gastrointestinal disorders | AZM-H (Withdrawal Phase) | 25 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Run-In | 0 | 289 |
| Total, all-cause mortality | Losartan (Double-Blind Phase) | 0 | 53 |
| Total, all-cause mortality | AZM-L (Double-Blind Phase) | 0 | 52 |
| Total, all-cause mortality | AZM-M (Double-Blind Phase) | 0 | 56 |
| Total, all-cause mortality | AZM-H (Double-Blind Phase) | 0 | 54 |
| Total, all-cause mortality | Placebo (Withdrawal Phase) | 0 | 103 |
| Total, all-cause mortality | Losartan (Withdrawal Phase) | 0 | 23 |
| Total, all-cause mortality | AZM-L (Withdrawal Phase) | 0 | 26 |
| Total, all-cause mortality | AZM-M (Withdrawal Phase) | 0 | 26 |
| Total, all-cause mortality | AZM-H (Withdrawal Phase) | 0 | 25 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02235909
GET https://conductscience.org/api/trials/v1/NCT02235909/flow?page=2