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HypertensionPhase 4NCT01964079

Comparision of Blood Pressure Variability Between Amlodipine and Losartan

A Phase 4 study testing Amlodipine and Losartan in people with Hypertension, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for hypertension are mainly focused on lowering mean BP. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Hypertension
What is being tested?
Amlodipine and Losartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteSouth Korea
Study dates
Apr 2013to May 2017
Phase
Phase 4
Are there results?
None posted in the registry

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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 20 years or older and below 80 years.
  • Patients who have not previously taken any antihypertensive drugs or have discontinued previous antihypertensive drugs for 2 weeks.
  • Mean SBP ≥140 mmHg or mean diastolic BP ≥ 90 mmHg (blood pressure will be checked at least 2 times in a seated position during the screening period).

Who cannot join

  • Pregnant women, possible candidate for pregnancy, or breastfeeding women.
  • Known or suspected secondary hypertension.
  • Mean seated SBP ≥ 180 mmHg and/or mean seated diastolic BP ≥ 120 mmHg at any visit.
  • Any clinically significant hepatic impairments.
  • Severe renal impairment (serum creatinine level > 3.0 mg/dL or creatinine clearance < 30 mL/min).
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, or post-renal transplant.
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  • Clinically relevant hyperkalemia.
  • Uncorrected volume or sodium depletion.
  • Suspected primary aldosteronism.
  • Hypertension and spontaneous or low-dose diuretic-induced hypokalemia.
  • Drug-resistant hypertension, defined as sub-optimally controlled hypertension on a 3-drug program that includes an adrenergic inhibitor, vasodilator, and diuretic.
  • Hypertension with adrenal incidentaloma.
  • Hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (<40 years).
  • Hypertensive first-degree relatives of patients with primary aldosteronism.
  • Symptomatic congestive heart failure.
  • Angina pectoris requiring treatment.
  • History of myocardial infarction or cerebrovascular accident (ischemic stroke or hemorrhage).
  • History of refractory or potentially lethal arrhythmias.
  • Concurrent participation in another clinical trial.
  • Patients with known intolerance, contraindication, or hypersensitivity to any component of dihydropyridines or angiotensin II receptor blockers.
  • Patients who are deemed unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 220-701

Other trials in South Korea

About this study

Official title: The COMPAriSon of Systolic Blood Pressure Variability and Central Blood Pressure of Calcium Channel Blocker (Amlodipine) in Comparison With Angiotensin Receptor Blocker (Losartan) in Patients With Essential Hypertension

Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for hypertension are mainly focused on lowering mean BP. However, despite an increasing incidence of stroke with age, the association between systolic BP (SBP) and the risk of stroke decreases with age. This disparity highlights a gap in the link between BP and vascular-related diseases (i.e., stroke). In clinical practice, visit-to-visit fluctuations in BP have been largely ignored and are thought to be an unreliable finding, even though this phenomenon is frequently observed. Rothwell et al. demonstrated that the visit-to-visit variability in SBP was a more powerful independent predictor of stroke than mean SBP, and that an increased residual variability in SBP in treated hypertensive patients was also a strong predictor of stroke and coronary events.

Recently updated (2011) hypertension guidelines from the National Institute for Health and Clinical Excellence (NICE) recommend an angiotensin converting enzyme inhibitor (ACEi) [or angiotensin II receptor blocker (ARB)] and calcium-channel blocker (CCB) as a first line drug. Although the significance of BP variability (BPV) has been illustrated, the main focus of the current guidelines is to reduce systolic and diastolic BP, not BPV.

In the X-CELLENT study, a CCB (amlodipine) and thiazide-like diuretic drug (indapamide sustained-release) led to a significant reduction in BPV, compared to an ARB (candesartan). In addition, the CCB showed the most effective reduction in systolic BPV among the antihypertensive drug class in a meta-analysis. However, there are no direct comparison studies of a CCB and ARB on BPV. Thus, we aim to compare the systolic BPV effects of a CCB versus an ARB in essential hypertensive patients. The primary hypothesis is that an ARB is not inferior to a CCB in the reduction of the systolic BPV standard deviation (SD) in essential hypertensive patients.

Conditions
Hypertension
Being tested
Amlodipine, Losartan
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlodipineDrug

    Also called Norvasc

    Eligible subjects will be randomized 1:1 to either an amlodipine or a losartan group by a computer-generated random number table. For patients who fail to respond to 5 mg amlodipine, the dose will be titrated up to 10 mg amlodipine. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.

  • LosartanDrug

    Also called Cozaar

    Eligible subjects will be randomized 1:1 to either an amlodipine or a losartan group by a computer-generated random number table. For patients who fail to respond to 50 mg losartan, the dose will be titrated up to 100 mg losartan. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.

Study groups in NCT01964079
Study groupRoleWhat they receive
CCB (amlodipine)Active comparatorFor patients who fail to respond to 5 mg oral amlodipine daily, the dose will be titrated up to 10 mg amlodipineh. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.
Receives: Drug: Amlodipine
ARB (losartan)Active comparatorFor patients who fail to respond to 50 mg oral losartan daily, the dose will be titrated up to 100 mg losartan. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.
Receives: Drug: Losartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SD of visit-to-visit systolic blood pressure variability

    Consecutive measured blood pressure values from each visit will be averaged, and the standard deviation (SD) is calculated using the mean systolic blood pressure of each visit.

    Measured: 6 months

Secondary outcomes (7)

  1. Central systolic blood pressure

    Measurement of central blood pressure will be performed at randomization and 6 months.

    Measured: 6 months

  2. Augmentation index of central blood pressure

    Augmentation index of central blood pressure will be measured at randomization and 6 months.

    Measured: 6 months

  3. Standard deviation of within-visit systolic blood pressure variability

    Measured: 6 months

  4. Coefficient of variation of visit-to-visit systolic blood pressure variability

    The coefficient of variation (CV) is defined as the standard deviation/mean systolic blood pressure.

    Measured: 6 months

  5. Variation independent of the mean of visit-to-visit systolic blood pressure variability

    To eliminate the correlation of coefficient variation with mean SBP, we will calculate a further transformed variable, the variation independent of the mean (VIM). The VIM is defined as the standard deviation/mean^x, with x estimated from curve fitting of the data.

    Measured: 6 months

  6. 24-h ambulatory blood pressure monitoring

    Measured: 6 months

  7. Home systolic blood pressure

    Home systolic blood pressure will be measured at each scheduled visit.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2017
  4. Study completionMay 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01964079
Sponsor's protocol ID
COMPASS-BPV
Status last verified
May 2017
First submitted
10 Oct 2013
Last updated
12 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amlodipine and Losartan in people with Hypertension, run by Wonju Severance Christian Hospital at 1 site in South Korea.

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 3 inclusion and 21 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 12 May 2017. 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 South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

SD of visit-to-visit systolic blood pressure variability (time frame: 6 months). 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 NCT01964079.

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 12 May 2017.

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