A Phase 4 interventional study of NICHE method and Usual care in Pediatric Hypertension, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 10 Years to 22 Years. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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Among 187 studies testing amlodipine in Hypertension — 7 open to participants now, 8 under way, 2 of them phase 3. Amlodipine · Hypertension.
Among the 187 studies testing amlodipine in Hypertension, this one is the 153rd largest by enrollment of the 186 interventional ones that give a count, is one of 5 that started in 2018, is one of 80 in phase 4, and was the 153rd registered.
6,118 studies on the registry are indexed under Hypertension; 914 are open to participants now.
Browse Hypertension studies →7 of the 187 studies testing amlodipine in Hypertension are open now, in 4 countries. Recruiting first, the newest first:
National Medical Research Center for Therapy and Preventive Medicine · Sites in Russia
Ages 50–70
Third Military Medical University · Sites in China
Ages 18–70
Shenzhen Ausa Pharmed Co.,Ltd · Sites in China
Ages 45–74
Shenzhen Ausa Pharmed Co.,Ltd · Sites in China
Ages 45–74
Hyundai Pharm · Sites in Korea, Republic of
Ages 19+
By country, each count listing its studies:
Amlodipine: first FDA approval 1992 (NORVASC), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 562 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 10 Years to 22 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 9 · Phase 3 71 · Phase 4 80
First in 1999; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 49 is below the median of 100 across 4,579 interventional studies indexed under Hypertension.
Median enrollment 180 across the 186 interventional studies. Of the 156 that completed or were terminated, 53 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
120 of 187 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 899 studies on the registry; 215 are open to participants now.
Of its 174 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 8 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 187 studies testing amlodipine in Hypertension, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control compared to usual care. This trial aims to advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.
Pediatric hypertension, a growing problem, often requires prescription of antihypertensive medication. Pediatric hypertension specialists lack an evidentiary base on which to establish definitive clinical practice guidelines for first-line therapy. Significant practice variation is an unsurprising consequence. Routine choice of the same first-line therapy for most patients with hypertension, absent testing other options, may delay correction of blood pressure for months or years. Failure to incorporate patient preferences in medical decision-making may also contribute to decreased patient satisfaction and adherence.
Large parallel-group, comparative effectiveness trials are likely not on the horizon for this population. Moreover, heterogeneity of treatment effects would minimize the generalizability of such a trial to all patients.
This is a parallel-group, randomized clinical trial to compare the n-of-1 trial approach to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the NICHE method, antihypertensive therapy will be chosen using an n-of-1 trial to identify the preferred therapy. Preferred therapy is defined a priori as that which produces the greatest reduction in ambulatory BP without intolerable side effects. Tested drugs will include amlodipine or losartan, lisinopril, and hydrochlorothiazide.
Other: NICHE method · Drug: Amlodipine · Drug: Lisinopril · Drug: Hydrochlorothiazide · Drug: Losartan
No protocol will be introduced to standardize BP management in the control arm.
Other: Usual care
Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.
Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
Calcium-channel blocker; antihypertensive
Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
Thiazide diuretic; antihypertensive
Angiotensin II receptor blocker (ARB); antihypertensive
Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months
Blood pressure control is when ambulatory blood pressure is normal, with normal as defined by the American Heart Association (AHA) criteria \[the AHA criteria are systolic blood pressure and diastolic blood pressure (throughout wake and sleep) less than the 95th percentile based on the patient's gender and height\]. To assess ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period.
Time frame: 6 months from enrollment
Change in Mean 24-hour Ambulatory Systolic Blood Pressure
To assess 24-hour mean ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period, while awake and while asleep. The mean of all recordings over the 24-hour period is calculated per participant for both baseline and 6 months, and then the mean 24-hour systolic blood pressure at 6 months minus the mean 24-hour systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.
Time frame: baseline, 6 months
Change in Mean Wake Ambulatory Systolic Blood Pressure
To assess mean wake ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24 hour period, throughout wake and sleep. The mean of all recordings that occur while the participant is awake during the 24-hour period is calculated for both baseline and 6 months, and then the mean wake systolic blood pressure at 6 months minus the mean wake systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.
Time frame: baseline, 6 months
Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication
Time frame: from baseline to 6 months
Number of Participants Who Self-reported Adherence to Intervention
Adherence is reported as the number of participants who self-reported at the 6-month visit that they had not missed any doses of their medication in the preceding month.
Time frame: from month 5 to month 6
Patient Satisfaction With Intervention as Assessed by a Survey
Patient satisfaction is scored from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible.
Time frame: 6 months
| Milestone | NICHE Method | Usual Care |
|---|---|---|
| Started | 23 | 26 |
| Received intervention | 21 | 22 |
| Completed 6-month follow up | 18 | 23 |
| Completed | 18 | 23 |
| Not completed | 5 | 3 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 |
Blood pressure control is when ambulatory blood pressure is normal, with normal as defined by the American Heart Association (AHA) criteria \[the AHA criteria are systolic blood pressure and diastolic blood pressure (throughout wake and sleep) less than the 95th percentile based on the patient's gender and height\]. To assess ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period.
| Participants | NICHE Method | Usual Care |
|---|---|---|
| Controlled | 8 | 8 |
| Uncontrolled | 10 | 15 |
To assess 24-hour mean ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period, while awake and while asleep. The mean of all recordings over the 24-hour period is calculated per participant for both baseline and 6 months, and then the mean 24-hour systolic blood pressure at 6 months minus the mean 24-hour systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.
| mmHg | NICHE Method | Usual Care |
|---|---|---|
| Change in Mean 24-hour Ambulatory Systolic Blood Pressure | -10.6 ± 9.301 | -5.1 ± 9.586 |
To assess mean wake ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24 hour period, throughout wake and sleep. The mean of all recordings that occur while the participant is awake during the 24-hour period is calculated for both baseline and 6 months, and then the mean wake systolic blood pressure at 6 months minus the mean wake systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.
| mmHg | NICHE Method | Usual Care |
|---|---|---|
| Change in Mean Wake Ambulatory Systolic Blood Pressure | -10.5 ± 7.747 | -6.2 ± 10.123 |
| Participants | NICHE Method | Usual Care |
|---|---|---|
| Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication | 0 | 3 |
Adherence is reported as the number of participants who self-reported at the 6-month visit that they had not missed any doses of their medication in the preceding month.
| Participants | NICHE Method | Usual Care |
|---|---|---|
| Number of Participants Who Self-reported Adherence to Intervention | 5 | 6 |
Patient satisfaction is scored from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible.
| score on a scale | NICHE Method | Usual Care |
|---|---|---|
| Patient Satisfaction With Intervention as Assessed by a Survey | 9.929 ± 0.267 | 9.667 ± 0.730 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NICHE Method | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Usual Care | 0/26 (0%) | 0/26 (0%) | 3/26 (11.5%) |
| Event | NICHE Method | Usual Care |
|---|---|---|
| DizzinessGastrointestinal disorders | 0/23 | 1/26 |
| TirednessGeneral disorders | 0/23 | 1/26 |
| Sleeping PoorlyGeneral disorders | 0/23 | 1/26 |
| Age, Continuous(years) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Median | 15.9 (14.7 to 16.9) | 15.9 (14.4 to 16.8) | 15.9 (14.7 to 16.9) |
| Sex: Female, Male(Participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 14 | 19 | 33 |
| Race/Ethnicity, Customized(Participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Hispanic (black or white) | 17 | 18 | 35 |
| White (non-Hispanic) | 1 | 1 | 2 |
| Black (non-Hispanic) | 5 | 6 | 11 |
| Asian | 0 | 0 | 0 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| United States | 23 | 26 | 49 |
| Primary language of parent(Participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| English | 11 | 13 | 24 |
| Spanish | 12 | 13 | 25 |
| Clinic Site(Participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Multidisciplinary HTN clinic | 12 | 14 | 26 |
| County based clinic | 11 | 12 | 23 |
| Hypertension type(Participants) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Primary | 17 | 22 | 39 |
| Secondary | 6 | 4 | 10 |
| Mean 24-hour ambulatory blood pressure at baseline (without medication)(mm Hg) | NICHE Method | Usual Care | Total |
|---|---|---|---|
| Systolic blood pressure | 130 (126 to 133) | 130 (127 to 134) | 130 (127 to 134) |
| Diastolic blood pressure | 76 (71 to 80) | 76 (74 to 81) | 76 (71 to 81) |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Nov 2020, 31 months.
Results were first posted in Sep 2022, 1 year 9 months after primary completion.
Of 126 non-industry phase 4 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 31 months is below that.
Counting every sponsor, half of 161 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amlodipine · Lisinopril · Hydrochlorothiazide · Losartan
The University of Texas Health Science Center, Houston →