Comparision of Blood Pressure Variability Between Amlodipine and Losartan

NCT01964079

Last updated date
Study Location
Wonju Severance Christian Hospital
Wonju, Gangwon-do, 220-701, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.


- Clinically relevant hyperkalemia.


- Uncorrected volume or sodium depletion.


- Suspected primary aldosteronism.


1. Hypertension and spontaneous or low-dose diuretic-induced hypokalemia.


2. Drug-resistant hypertension, defined as sub-optimally controlled hypertension on
a 3-drug program that includes an adrenergic inhibitor, vasodilator, and
diuretic.


3. Hypertension with adrenal incidentaloma.


4. Hypertension and a family history of early-onset hypertension or cerebrovascular
accident at a young age (<40 years).


5. 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparision of Blood Pressure Variability Between Amlodipine and Losartan
Official Title  ICMJE 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
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Amlodipine
    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.
    Other Name: Norvasc
  • Drug: Losartan
    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.
    Other Name: Cozaar
Study Arms  ICMJE
  • Active Comparator: CCB (amlodipine)
    For 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.
    Intervention: Drug: Amlodipine
  • Active Comparator: ARB (losartan)
    For 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.
    Intervention: Drug: Losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2017)
144
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2013)
162
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Clinically relevant hyperkalemia.
  • Uncorrected volume or sodium depletion.
  • Suspected primary aldosteronism.

    1. Hypertension and spontaneous or low-dose diuretic-induced hypokalemia.
    2. Drug-resistant hypertension, defined as sub-optimally controlled hypertension on a 3-drug program that includes an adrenergic inhibitor, vasodilator, and diuretic.
    3. Hypertension with adrenal incidentaloma.
    4. Hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (<40 years).
    5. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964079
Other Study ID Numbers  ICMJE COMPASS-BPV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Byung-Su Yoo, Wonju Severance Christian Hospital
Study Sponsor  ICMJE Wonju Severance Christian Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Byung-Su Yoo, MD, PhDWonju Severance Christian Hospital
PRS Account Wonju Severance Christian Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP