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Study to Confirm the Efficacy and Safety of Fixed-dose Combinations of Amlodipine and Candesartan (MACH)

15. oktober 2018 opdateret af: HK inno.N Corporation

A Randomized, Double-blind, Multi-center, Phase Ⅳ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety Between Amlodipine Besylate/Candesartan Cilexetil Combination Tablets and Co-administration of Amlodipine Besylate and Candesartan Cilexetil in Patients With Essential Hypertension

To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil administered in a fixed-dose combination tablet versus co-administered as their separate formulations in patients with essential hypertension who have shown inadequate response on monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil single agents

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

210

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken
        • Rekruttering
        • Yonsei University Severance Cardiovascular Hospital
        • Kontakt:
          • Donghoon Choi, M.D., Ph.D.
          • Telefonnummer: 82-2-2228-8200
          • E-mail: cdhlyj@yuhs.ac

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult male and female aged 19 to 75 years

  2. Diagnosed with essential hypertension

    Patients with essential hypertension meeting one of the following two inclusion criteria:

    2.1. Patients with essential hypertension who have shown inadequate response (mean siSBP ≥ 140 mmHg or mean siDBP ≥ 90 mmHg) to treatment with amlodipine or candesartan cilexetil.

    2.2. Patients with essential hypertension with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil (mean siSBP < 140 mmHg and mean siDBP < 90 mmHg).

  3. Voluntarily consented to participate in the study and signed the informed consent form after receiving the explanation of the objectives, methods and effects of the study.

Exclusion Criteria:

  1. The difference in blood pressure between the selected arm versus non-selected arm is ≥ 20 mmHg for siSBP and ≥ 10 mmHg for siDBP at Visit 1 (screening).
  2. Blood pressure taken at screening and randomization is ≥ 180 mmHg for siSBP or ≥ 110 mmHg for siDBP.
  3. Diagnosed with secondary hypertension or suspected of secondary hypertension [e.g., renovascular disease, adrenal medullary and cortical hyperfunction, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.]
  4. Patients with symptomatic orthostatic hypertension (the difference in the blood pressures between measured at supine position and measured at standing position is ≥ 20 mmHg for siSBP and ≥ 10 mmHg for siDBP)
  5. Diagnosis of type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or with HbA1c > 9%)
  6. Patients with severe cardiac conditions: heart failure (NYHA Class 3 or 4), history of ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular diseases, percutaneous transluminal angioplasty or coronary artery bypass graft within recent 6 months.
  7. Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia at the discretion of the investigator
  8. Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis
  9. History of cardiogenic shock
  10. Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction or cerebral hemorrhage within recent 6 months)
  11. History or current evidence of wasting, autoimmune (such as rheumatoid arthritis and systemic lupus erythematosus) or connective tissue diseases
  12. Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage, visual disturbance and retinal microaneurysm within 6 months)
  13. Patients with surgical or medical intestinal diseases or having received surgeries that could interfere with drug absorption distribution, metabolism and elimination
  14. History of malignancy including leukemia and lymphoma within recent 5 years except for localized basal cell carcinoma of the skin)
  15. Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy
  16. Renal failure on dialysis

  17. Laboratory abnormalities as follows:

    • AST or ALT >2 x upper limit of normal (ULN)
    • Serum creatinine > 1.5 x ULN
    • Serum potassium < 3.5 mmol/L or >5.5 mmol/L
  18. Needs for co-administration of non-study antihypertensive agents or contraindicated medications during the study
  19. History of hypersensitivity to ARBs or dihydropyridines
  20. History of angioedema to treatment with ACE inhibitors or ARBs
  21. Pregnant or lactating women and female volunteers of childbearing potential (except for women who are surgically sterile) who are not willing to use an adequate method of contraception (oral contraceptives, intrauterine device, condom, etc.) during the study. Women of childbearing potential who are not surgically sterile will be allowed to participate in the study only if they have negative pregnancy test at Visit 1 (screening) and should continue to use medically acceptable method of contraception (basic body temperature method and rhythm method will not be allowed). Women with no menses for ≥ 12 months will be considered as postmenopausal state and method of contraception using hormonal contraception such as oral contraceptive should be initiated from or prior to the screening.
  22. History of drug or alcohol abuse within recent 1 year
  23. Patients having received any other investigational product within recent 12 weeks
  24. Conditions which render a subject ineligible for the study at the discretion of the investigator

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group I
Fixed-Dose combination of Candesartan cilexetil 8mg and Amlodipine 5mg(or Fixed-Dose combination of Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
Medicin: Group I
Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks
Andre navne:
  • Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)
Aktiv komparator: Group II
Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
Medicin: Group II
Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks
Andre navne:
  • Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment
Tidsramme: Week 8

For change in siSBP from baseline after 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.

The LS mean change in siSBP from baseline after 8 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 8 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in siSBP from baseline after 4 weeks of treatment
Tidsramme: Week 4

For change in siSBP from baseline after 4 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.

The LS mean change in siSBP from baseline after 4 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 4 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Week 4
Change in siDBP from baseline after 4 and 8 weeks of treatment
Tidsramme: Week 4 and Week 8

For change in siDBP from baseline after 4 and 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm.

The LS mean change in siSBP from baseline after 4 and 8 weeks of treatment adjusted for baseline siDBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siDBP from baseline after 4 and 8 weeks of treatment as response variable and baseline siDBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Week 4 and Week 8
Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment
Tidsramme: Week8
The frequency and percentage of subjects with siDBP < 90 mmHg and the frequency and percentage of subjects with siSBP < 140 mmHg after 8 weeks of treatment will be presented by treatment arm. Additionally, the frequency and percentage of subjects with both siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment will be presented by treatment arm. The difference in proportion between treatment arms will be tested using the χ2 test or Fisher's exact test.
Week8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: Baseline, Week 4 and Week 8

All patients treated with the investigational product will be included in the safety analyses. For adverse events, adverse drug reactions and serious adverse events, the number of subjects experiencing the events or reactions, 95% 2-sided CI, incidence rate, and number of the events or reactions will be presented by treatment arm. The difference in the incidence between the treatment arms will be tested using the χ2 test or Fisher's exact test. The incidence and percentage of events by severity, causality, actions taken and outcome will be presented by treatment arm.

All AEs will be coded per system organ class (SOC) and preferred term (PT) using the MedDRA; for each coded event, the number and percentage of subjects and the number of cases will be summarized by treatment arm. In addition, for each coded event, the number and percentage of subjects by severity, causality, actions taken and outcome will be presented by treatment arm.
Baseline, Week 4 and Week 8
Clinical laboratory tests
Tidsramme: Baseline, Wee4 and Week 8
For continuous variables in clinical laboratory test items, the mean, standard deviation, minimum and maximum of baseline value, post-baseline values and change form baseline to post-baseline will be presented by treatment arm. The difference in change from baseline to post-baseline between treatment arms will be tested using the unpaired t-test or Wilcoxon's rank sum test depending on the normality. The intra-arm change from baseline to post-baseline will be tested using the paired t-test or Wilcoxon's signed rank test depending on the normality. For categorical variables, the shift table for frequency and percentage will be presented. The difference in the percentage of subjects whose test results changed from 'normal' to 'abnormal' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
Baseline, Wee4 and Week 8
Electrocardiogram (ECG)
Tidsramme: Screening and Week 8
For each ECG parameters at baseline and post-baseline, the shift table will be presented with frequency and percentage. The difference in the percentage of subjects whose ECG results changed from 'clinically insignificant' to 'clinically significant' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
Screening and Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HK inno.N Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. april 2017

Primær færdiggørelse (Forventet)

30. april 2019

Studieafslutning (Forventet)

31. maj 2019

Datoer for studieregistrering

Først indsendt

25. juli 2017

Først indsendt, der opfyldte QC-kriterier

25. juli 2017

Først opslået (Faktiske)

27. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CJ_CCA_401

Plan for individuelle deltagerdata (IPD)

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