Essential HypertensionNCT02412761
Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension
A study testing Lisinopril, Amlodipine and Hydrochlorothiazide in people with Essential Hypertension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension. Read more about this study
- Who is it for?
- Ages 9 to 22 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Lisinopril, Amlodipine and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of essential hypertension
- Treating physician has determined that pharmacologic therapy is necessary
Who cannot join
- Compelling indication to select one particular medication
- Specific contraindication for any of the 3 therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics
Houston, Texas, 77030
About this study
Children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension.
This study will consist of a series of systematically-administered n-of-1 trials among children to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy.
Read the detailed description
This is a series of systematically-administered n-of-1 trials among children with essential hypertension to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy from among the three major classes of drugs commonly used for essential hypertension (angiotensin converting enzyme inhibitors, calcium channel blockers, and diuretics). The investigators will determine whether there is one that is preferred for the great majority of patients. The "preferred" therapy will be defined as the drug which produces normal ambulatory blood pressure, with the greatest reduction in awake mean systolic blood pressure without unacceptable side effects.
For each patient, the order of the 3 drugs will be assigned randomly and each drug will be taken for 2 weeks. The effectiveness of each drug will be measured with 24-hour ambulatory blood pressure monitoring, and tolerability will be assessed using a side effect questionnaire. Participants will rotate through treatment periods, repeating drugs and adjusting doses until the preferred therapy is identified. In assessing whether one the medications is most effective for the great majority of subjects, the primary outcome will be the percentage of participants for whom each drug is selected as the preferred therapy. Primary hypothesis: no drug will be selected for the majority of the subjects, a finding that would support consideration of clinical use of n-of-1 trials. Secondary analyses will explore whether patient characteristics predict which medication will be selected as a preferred drug.
- Conditions
- Essential Hypertension
- Being tested
- Lisinopril, Amlodipine, Hydrochlorothiazide
- Keywords
- Anti-hypertensive medications, Pediatrics, N-of-1 trial
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisinoprilDrug
Also called Angiotensin-converting enzyme inhibitor
Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 10 mg/dose). Maximum final dose: 40 mg/dose or 0.6 mg/kg/dose.
AmlodipineDrug
Also called Dihydropyridine calcium channel blocker
Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 5 mg/dose). Maximum final dose: 10 mg/dose
HydrochlorothiazideDrug
Also called Thiazide diuretic
Initial dose: 1 mg/kg/dose orally, once daily (maximum initial dose 25 mg/dose). Maximum final dose: 50 mg/dose or 3 mg/kg/dose
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine, then HCTZ, then Lisinopril | Active comparator | Participants first received amlodipine once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
| Amlodipine, then Lisinopril, then HCTZ | Active comparator | Participants first received amlodipine once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
| HCTZ, then Amlodipine, then Lisinopril | Active comparator | Participants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
| HCTZ, then Lisinopril, then Amlodipine | Active comparator | Participants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
| Lisinopril, then Amlodipine, then HCTZ | Active comparator | Participants first received lisinopril once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
| Lisinopril, then HCTZ, then Amlodipine | Active comparator | Participants first received lisinopril once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. Receives: Drug: Lisinopril; Drug: Amlodipine; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy
For each n-of-1 trial, the preferred drug is defined as that which produces normal ambulatory blood pressure (by pediatric Ambulatory blood pressure monitoring (ABPM) standards), with the greatest magnitude of wake mean systolic BP reduction, and without unacceptable side effects.
Measured: The outcome of BP control and side effect tolerability will be assessed 2 weeks after starting each drug. Participants will be followed for an average of 10-12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Philip Samuel, The University of Texas Health Science Center, Houston
- Investigators
- Joyce P Samuel, MD, MS, Principal investigator, University of Texas at Houston Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412761
- Sponsor's protocol ID
- HSC-MS-13-0287
- Other IDs
- 5KL2TR000370
- Status last verified
- Nov 2018
- First submitted
- 3 Apr 2015
- Last updated
- 15 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samuel JP, Samuels JA, Brooks LE, Bell CS, Pedroza C, Molony DA, Tyson JE. Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials. Trials. 2016 Jan 8;17:16. doi: 10.1186/s13063-015-1142-y.
PubMed 26746195Samuel JP, Tyson JE, Green C, Bell CS, Pedroza C, Molony D, Samuels J. Treating Hypertension in Children With n-of-1 Trials. Pediatrics. 2019 Apr;143(4):e20181818. doi: 10.1542/peds.2018-1818. Epub 2019 Mar 6.
PubMed 30842257
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02412761
- Acronym / sponsor ID
- HSC-MS-13-0287
- Conditions
- Essential Hypertension
- Keywords
- Anti-hypertensive medications, Pediatrics, N-of-1 trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 15 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension.
This study will consist of a series of systematically-administered n-of-1 trials among children to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy.
Detailed description
This is a series of systematically-administered n-of-1 trials among children with essential hypertension to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy from among the three major classes of drugs commonly used for essential hypertension (angiotensin converting enzyme inhibitors, calcium channel blockers, and diuretics). The investigators will determine whether there is one that is preferred for the great majority of patients. The "preferred" therapy will be defined as the drug which produces normal ambulatory blood pressure, with the greatest reduction in awake mean systolic blood pressure without unacceptable side effects.
For each patient, the order of the 3 drugs will be assigned randomly and each drug will be taken for 2 weeks. The effectiveness of each drug will be measured with 24-hour ambulatory blood pressure monitoring, and tolerability will be assessed using a side effect questionnaire. Participants will rotate through treatment periods, repeating drugs and adjusting doses until the preferred therapy is identified. In assessing whether one the medications is most effective for the great majority of subjects, the primary outcome will be the percentage of participants for whom each drug is selected as the preferred therapy. Primary hypothesis: no drug will be selected for the majority of the subjects, a finding that would support consideration of clinical use of n-of-1 trials. Secondary analyses will explore whether patient characteristics predict which medication will be selected as a preferred drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Amlodipine, then HCTZ, then Lisinopril | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received amlodipine once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
| Amlodipine, then Lisinopril, then HCTZ | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received amlodipine once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
| HCTZ, then Amlodipine, then Lisinopril | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then lisinopril once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
| HCTZ, then Lisinopril, then Amlodipine | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received hydrochlorothiazide (HCTZ) once daily for 2 weeks, then crossed over to lisinopril once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
| Lisinopril, then Amlodipine, then HCTZ | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received lisinopril once daily for 2 weeks, then crossed over to amlodipine once daily for 2 weeks, then hydrochlorothiazide (HCTZ) once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
| Lisinopril, then HCTZ, then Amlodipine | Active comparator | Drug: Lisinopril, Drug: Amlodipine, Drug: HydrochlorothiazideParticipants first received lisinopril once daily for 2 weeks, then crossed over to hydrochlorothiazide (HCTZ) once daily for 2 weeks, then amlodipine once daily for 2 weeks. Subsequent treatments varied depending on individual patient response. |
Who may qualify
- Ages
- 9 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of essential hypertension
- Treating physician has determined that pharmacologic therapy is necessary
Key exclusion criteria (2 listed)
- Compelling indication to select one particular medication
- Specific contraindication for any of the 3 therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisinoprilAlso: Angiotensin-converting enzyme inhibitorInitial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 10 mg/dose). Maximum final dose: 40 mg/dose or 0.6 mg/kg/dose. | Drug | Amlodipine, then HCTZ, then Lisinopril, Amlodipine, then Lisinopril, then HCTZ, HCTZ, then Amlodipine, then Lisinopril, HCTZ, then Lisinopril, then Amlodipine, Lisinopril, then Amlodipine, then HCTZ, Lisinopril, then HCTZ, then Amlodipine |
| AmlodipineAlso: Dihydropyridine calcium channel blockerInitial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 5 mg/dose). Maximum final dose: 10 mg/dose | Drug | Amlodipine, then HCTZ, then Lisinopril, Amlodipine, then Lisinopril, then HCTZ, HCTZ, then Amlodipine, then Lisinopril, HCTZ, then Lisinopril, then Amlodipine, Lisinopril, then Amlodipine, then HCTZ, Lisinopril, then HCTZ, then Amlodipine |
| HydrochlorothiazideAlso: Thiazide diureticInitial dose: 1 mg/kg/dose orally, once daily (maximum initial dose 25 mg/dose). Maximum final dose: 50 mg/dose or 3 mg/kg/dose | Drug | Amlodipine, then HCTZ, then Lisinopril, Amlodipine, then Lisinopril, then HCTZ, HCTZ, then Amlodipine, then Lisinopril, HCTZ, then Lisinopril, then Amlodipine, Lisinopril, then Amlodipine, then HCTZ, Lisinopril, then HCTZ, then Amlodipine |
Primary outcome
The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy
Time frame: The outcome of BP control and side effect tolerability will be assessed 2 weeks after starting each drug. Participants will be followed for an average of 10-12 weeks.
For each n-of-1 trial, the preferred drug is defined as that which produces normal ambulatory blood pressure (by pediatric Ambulatory blood pressure monitoring (ABPM) standards), with the greatest magnitude of wake mean systolic BP reduction, and without unacceptable side effects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26746195Samuel JP, Samuels JA, Brooks LE, Bell CS, Pedroza C, Molony DA, Tyson JE. Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials. Trials. 2016 Jan 8;17:16. doi: 10.1186/s13063-015-1142-y.
- Derived from this study: PubMed 30842257Samuel JP, Tyson JE, Green C, Bell CS, Pedroza C, Molony D, Samuels J. Treating Hypertension in Children With n-of-1 Trials. Pediatrics. 2019 Apr;143(4):e20181818. doi: 10.1542/peds.2018-1818. Epub 2019 Mar 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce P Samuel, MD, MS principal investigator
University of Texas at Houston Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lisinopril, Amlodipine and Hydrochlorothiazide in people with Essential Hypertension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy (time frame: The outcome of BP control and side effect tolerability will be assessed 2 weeks after starting each drug. Participants will be followed for an average of 10-12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412761, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.