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Hypertension, HyperlipidemiaPhase 4REVERT-KNCT03847506

Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets

A Phase 4 study testing Ezetimibe/Rosuvastatin, Candesartan cilexetil/Amlodipine besylate and Candesartan cilexetil in people with Hypertension, Hyperlipidemia, run by HK inno.N Corporation 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
Search all trials

Trial summary

To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets compared to each combination tablet alone in patients with essential hypertension (HTN) and hyperlipidemia. Read more about this study

Who is it for?
Ages 19 to 74 years
Conditions the study is for
Hypertension, Hyperlipidemia
What is being tested?
Ezetimibe/Rosuvastatin, Candesartan cilexetil/Amlodipine besylate and Candesartan cilexetil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteSouth Korea
Study dates
5 Jul 2018to 2 Dec 2020
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 19 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

[ Inclusion Criteria ]

  1. Adults aged 19 to <75 years.
  2. Diagnosed with essential HTN accompanied by hyperlipidemia (average siSBP ≥140 mmHg and LDL-C ≥100 mg/dL) or being treated for the condition after the diagnosis, at Visit 1 (screening).
  3. Provided the signed informed consent form voluntarily after receiving explanation of the objectives, methods and effects of the study.
  4. Medically sterile or agreed to use medically acceptable contraceptive method during the study.

[ Exclusion Criteria ]

  • Criteria Related to HTN and Dyslipidemia
  1. Severe HTN defined as average siDBP ≥110 mmHg or average siSBP ≥180 mmHg at Visit 1 (screening).
  2. The difference in BPs between those measured at both arms at Visit 1 (screening) is ≥10 mmHg for siDBP or ≥20 mmHg for siSBP.
  3. LDL-C >250 mg/dL or TG ≥400 mg/dL at Visit 1 (screening).
  4. Diagnosed with or suspected of secondary HTN (e.g., renovascular disease, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.).
  5. Patients with symptomatic orthostatic HTN (difference in BPs between the value measured in supine position and the value measured in standing position is ≥20 mmHg for siSBP or ≥10 mmHg for siDBP).
  • Criteria Related to Medical History
  1. Diagnosis with type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or patients with HbA1C ≥9%).
  2. Patients with severe heart disease - heart failure (NYHA Classes 3 and 4), history of ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular diseases, percutaneous transluminal angioplasty, or coronary artery bypass graft within the recent 3 months.
  3. Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other clinically significant arrhythmia at the discretion of the investigator.
  4. History of muscular toxicity while on treatment with other HMG-CoA reductase inhibitors or fibrates.
  5. History of angioedema while on treatment with ACE inhibitors or ARBs.
  6. History of hypersensitivity to ARBs, dihydropyridines, or HMG-CoA reductase inhibitors.
  7. Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery disease, aortic stenosis, hemodynamically significant aortic, or mitral valve stenosis.
  8. Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction, or cerebral hemorrhage within the recent 6 months).
  9. History or current evidence of wasting diseases, autoimmune diseases (such as rheumatoid arthritis and systemic lupus erythematosus), or connective tissue diseases.
  10. Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage, visual disturbance, and retinal microaneurysm within the recent 6 months).
  11. Patients with surgical or medical gastrointestinal diseases or having received surgery that could interfere with drug absorption, distribution, metabolism, and elimination and patients with active gastritis, gastrointestinal/rectal bleeding, or diagnosed with active inflammatory bowel disease within the recent 12 months.
  12. History of malignancy including leukemia and lymphoma within the recent 5 years (except for localized basal cell carcinoma of the skin).
  13. Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy.
  14. Patients who received kidney transplant or with only one kidney.
  15. Presence of biliary obstruction or cholestasis.
  16. Presence of hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  17. Patients with shock.
  • Criteria Related to Clinical Laboratory Tests
  1. Laboratory abnormalities as follows:
  • AST or ALT >3 x upper limit of normal (ULN);
  • Serum creatinine >1.5 x ULN.
  1. History of myopathy or rhabdomyolysis (e.g., serum CK ≥5 x ULN).
  2. Uncontrolled abnormal thyroid function (e.g., TSH ≥1.5 x ULN).
  3. Persistent abnormal serum potassium level (e.g., serum potassium level <3.5 mmol/L or >5.5 mmol/L).
  4. Patients with conditions of body fluid depletion or laboratory findings indicating clinically significant electrolyte abnormality.
  • Others
  1. Needs for concomitant administration of non-study antihypertensive agents or prohibited medications during the study.
  2. Pregnant or lactating women.
  3. History of drug or alcohol abuse within the recent 1 year.
  4. Having received other investigational product within 4 weeks prior to screening.
  5. Patients considered ineligible for the study at the discretion of the principal investigator (PI) or study staff.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Bundang Seoul National University Hospital

    Gyeonggi-do, Seongnam-si, Bundang-gu, 13620

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin Combination Tablets and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets

To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets compared to each combination tablet alone in patients with essential hypertension (HTN) and hyperlipidemia.

Read the detailed description

To improve the ease of use of high blood pressure and hyperlipidemia to improve patient compliance and reduce the risk of cardiovascular disease.

And It is recommended to identify the need to develop a combination of Candesartan cilexetil/Amlodipine besylate combination tablets , and Ezetimibe/Rosuvastatin combination tablets.

Being tested
Ezetimibe/Rosuvastatin, Candesartan cilexetil/Amlodipine besylate, Candesartan cilexetil
Medical subject headings
Hypertension, Hyperlipidemias

What participants receive

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

  • Ezetimibe/RosuvastatinDrug

    Also called Ezetimibe/Rosuvastatin 10 mg/10 mg

    Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Candesartan cilexetil 8 mg placebo

  • Candesartan cilexetil/Amlodipine besylateDrug

    Also called Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg

    Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Ezetimibe/Rosuvastatin 10 mg/10 mg placebo + Candesartan cilexetil 8 mg placebo

  • Candesartan cilexetilDrug

    Also called Candesartan cilexetil 8 mg

    Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg placebo

Study groups in NCT03847506
Study groupRoleWhat they receive
EZE/ROS+CAN/AMLExperimentalEzetimibe/Rosuvastatin 10 mg/10 mg and Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks
Receives: Drug: Ezetimibe/Rosuvastatin
CAN/AMLActive comparatorCandesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks
Receives: Drug: Candesartan cilexetil/Amlodipine besylate
EZE/ROS+CANActive comparatorEzetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg, once a day for 6 weeks
Receives: Drug: Candesartan cilexetil

What is being measured

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

  1. Change in sitting Systolic Blood Pressure(siSBP) from baseline after 6 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm

    Change in siSBP from baseline after 6 weeks of study treatment For the siSBP at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the analysis of covariance (ANCOVA) with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.

    Measured: week 6

  2. Percentage change in LDL-C levels from baseline after 6 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. CAN/AML arm

    Percentage change in LDL-C levels from baseline after 6 weeks of study treatment For the percentage change in LDL-C levels at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.

    Measured: week 6

Secondary outcomes (9)

  1. Change in siSBP from baseline after 3 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm

    For the siSBP at baseline and after 3 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 3 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.

    Measured: week 3

  2. Percentage changes in LDL-C levels from baseline after 3 and 6 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm

    For the LDL-C levels at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage changes in baseline-adjusted LDL-C levels from baseline after 3 and 6 weeks of study treatment and their standard error will be provided by treatment arm. Inter-arm comparisons of the percentage changes in LDL-C levels at Week 3 and Week 6 will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.

    Measured: week 3 and week 6

  3. Percentage change in LDL-C levels from baseline after 3 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. CAN/AML arm

    For the percentage change in LDL-C levels at baseline and after 3 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 3 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.

    Measured: week 3

  4. Changes in siSBPs from baseline after 3 and 6 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. CAN/AML arm

    For the siSBP at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 3 and 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.

    Measured: week 3 and week 6

  5. Percentage changes in LDL-C/HDL-C and TC/HDL-C from baseline after 3 and 6 weeks of study treatment

    EZE/ROS + CAN/AML arm vs. CAN/AML arm

    For the LDL-C/HDL-C and TC/HDL-C at baseline and for their percentage changes after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum were presented by treatment arm. The LS-mean percentage changes in baseline-adjusted LDL-C/HDL-C and TC/HDL-C levels from baseline after 3 and 6 weeks of study treatment and their standard errors will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage changes in LDL-C/HDL-C and TC/HDL-C levels as response variables and baseline LDL-C/HDL-C and TC/HDL-C levels and treatment arm as independent variables.

    Measured: week 3 and week 6

  6. Changes in siDBPs from baseline after 3 and 6 weeks of study treatment

    Co-Endpoints

    For the siDBP at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siDBP from baseline after 3 and 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siDBP as response variable and baseline siDBP and treatment arm as independent variables.

    Measured: week 3 and week 6

  7. Proportions of subjects who achieve the treatment goal based on JNC VIII Guideline from baseline after 3 and 6 weeks of study treatment

    Co-Endpoints

    (HTN treatment goal: <140/90 mmHg [or <150/90 mmHg for patients aged ≥60 years]) The frequencies and proportions of subjects who achieve the treatment goal based on JNC VIII Guideline from baseline after 3 and 6 weeks of study treatment will be provided by treatment arm. The differences in the proportions of subjects who achieve the treatment goal after 3 and 6 weeks of study treatment between treatment arms will be analyzed using the Pearson's chi-square test or the Fisher's exact test.

    Measured: week 3 and week 6

  8. Proportions of subjects who achieve the treatment goal based on NCEP ATP III Guideline from baseline after 3 and 6 weeks of study treatment

    Co-Endpoints

    (LDL-C treatment goal - Group I: <160 mg/dL; Group II: <130 mg/dL; and Group III: <100 mg/dL) The frequencies and proportions of subjects who achieve the treatment goal based on NCEP ATP III Guideline from baseline after 3 and 6 weeks of study treatment will be provided by treatment arm. The differences in the proportions of subjects who achieve the treatment goal after 3 and 6 weeks of study treatment between treatment arms will be analyzed using the Pearson's chi-square test or the Fisher's exact test.

    Measured: week 3 and week 6

  9. Percentage changes in TC, TG, HDL-C, apolipoprotein B, and CRP levels from baseline after 3 and 6 weeks of study treatment

    Co-Endpoints

    For the TC, TG, HDL-C, apolipoprotein B, and CRP levels at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage changes in baseline-adjusted TC, TG, HDL-C, apolipoprotein B, and CRP levels from baseline after 3 and 6 weeks of study treatment and their standard error will be provided by treatment arm. Inter-arm comparisons of the percentage changes at Week 3 and Week 6 will be conducted using the ANCOVA with each percentage change in TC, TG, HDL-C, apolipoprotein B, and CRP levels as response variable and relevant baseline level and treatment arm as independent variables.

    Measured: week 3 and week 6

Timeline

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

  1. First posted20 Feb 2019
  2. Study start5 Jul 2018
  3. Primary completion2 Dec 2020
  4. Study completion2 Dec 2020

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
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847506
Sponsor's protocol ID
CJ_RVZ_401
Acronym
REVERT-K
Status last verified
May 2022
First submitted
20 Nov 2018
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ezetimibe/Rosuvastatin, Candesartan cilexetil/Amlodipine besylate and Candesartan cilexetil in people with Hypertension, Hyperlipidemia, run by HK inno.N Corporation 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?

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 10 May 2022. 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?

Change in sitting Systolic Blood Pressure(siSBP) from baseline after 6 weeks of study treatment (time frame: week 6). The study lists 2 primary outcomes in all. 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 NCT03847506.

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 10 May 2022.

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