HypertensionNCT01658657
A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
A study testing Hydrochlorothiazide, Lisinopril and Amlodipine in people with Hypertension and Plasma Renin Activity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Plasma Renin Activity
- What is being tested?
- Hydrochlorothiazide, Lisinopril and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
- Not currently taking BP-lowering medication
- Clinician recommends pharmacologic treatment
- Willing to make necessary study visits
- Able to be contacted by phone
- Has a primary care clinician
- At least 18 years old
Who cannot join
- Known secondary cause of hypertension
- Pregnancy
- Known diabetes, coronary artery disease or renal disease
- Known sulfonamide allergy or history of gout
- Participant's clinician recommends he/she not enroll
- Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
- Baseline visit systolic visit BP average < 140 mmHg and diastolic BP average < 90 mm Hg
- Resting heart rate < 55 beats per minute
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.
- Conditions
- Hypertension, Plasma Renin Activity
- Being tested
- Hydrochlorothiazide, Lisinopril, Amlodipine, metoprolol, lisinopril/hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
LisinoprilDrug
AmlodipineDrug
metoprololDrug
lisinopril/hydrochlorothiazideDrug
This is a combination pill
| Study group | Role | What they receive |
|---|---|---|
| PRA-guided therapy | Experimental | Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. Receives: Drug: Hydrochlorothiazide; Drug: Lisinopril; Drug: Amlodipine; Drug: metoprolol |
| Fixed-dose combination treatment-guided therapy | Active comparator | Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. Receives: Drug: Amlodipine; Drug: metoprolol; Drug: lisinopril/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
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.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Anthony Viera, MD, MPH, Principal investigator, Distinguished Associate Professor, Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658657
- Sponsor's protocol ID
- 12-1133
- Status last verified
- Aug 2015
- First submitted
- 31 Jul 2012
- Last updated
- 27 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
- ClinicalTrials.gov ID
- NCT01658657
- Acronym / sponsor ID
- 12-1133
- Conditions
- Hypertension, Plasma Renin Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cornell University, Wake Forest University Health Sciences
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Posted 22 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRA-guided therapy | Experimental | Drug: Hydrochlorothiazide, Drug: Lisinopril, Drug: Amlodipine, Drug: metoprololParticipants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. |
| Fixed-dose combination treatment-guided therapy | Active comparator | Drug: Amlodipine, Drug: metoprolol, Drug: lisinopril/hydrochlorothiazideParticipants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
- Not currently taking BP-lowering medication
- Clinician recommends pharmacologic treatment
- Willing to make necessary study visits
- Able to be contacted by phone
Key exclusion criteria (8 listed)
- Known secondary cause of hypertension
- Pregnancy
- Known diabetes, coronary artery disease or renal disease
- Known sulfonamide allergy or history of gout
- Participant's clinician recommends he/she not enroll
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 |
|---|---|---|
| Hydrochlorothiazide | Drug | PRA-guided therapy |
| Lisinopril | Drug | PRA-guided therapy |
| Amlodipine | Drug | Fixed-dose combination treatment-guided therapy, PRA-guided therapy |
| metoprolol | Drug | Fixed-dose combination treatment-guided therapy, PRA-guided therapy |
| lisinopril/hydrochlorothiazideThis is a combination pill | Drug | Fixed-dose combination treatment-guided therapy |
Primary outcome
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
Time frame: 4 months
At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony Viera, MD, MPH principal investigator
Distinguished Associate Professor, Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrochlorothiazide, Lisinopril and Amlodipine in people with Hypertension and Plasma Renin Activity, run by University of North Carolina, Chapel Hill 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 7 inclusion and 8 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 27 Aug 2015. 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 22 Jun 2015). 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?
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2015.