HypertensionPhase 4MACHNCT03231982
Study to Confirm the Efficacy and Safety of Fixed-dose Combinations of Amlodipine and Candesartan
A Phase 4 study testing Group I and Group II in people with Hypertension, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Group I and Group II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2017to 31 May 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female aged 19 to 75 years
- 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).
- 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.
Who cannot join
- 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).
- Blood pressure taken at screening and randomization is ≥ 180 mmHg for siSBP or ≥ 110 mmHg for siDBP.
- 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.]
- 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)
- Diagnosis of type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or with HbA1c > 9%)
- 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.
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- Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia at the discretion of the investigator
- Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis
- History of cardiogenic shock
- Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction or cerebral hemorrhage within recent 6 months)
- History or current evidence of wasting, autoimmune (such as rheumatoid arthritis and systemic lupus erythematosus) or connective tissue diseases
- Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage, visual disturbance and retinal microaneurysm within 6 months)
- Patients with surgical or medical intestinal diseases or having received surgeries that could interfere with drug absorption distribution, metabolism and elimination
- History of malignancy including leukemia and lymphoma within recent 5 years except for localized basal cell carcinoma of the skin)
- Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy
- Renal failure on dialysis
- 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
- Needs for co-administration of non-study antihypertensive agents or contraindicated medications during the study
- History of hypersensitivity to ARBs or dihydropyridines
- History of angioedema to treatment with ACE inhibitors or ARBs
- 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.
- History of drug or alcohol abuse within recent 1 year
- Patients having received any other investigational product within recent 12 weeks
- Conditions which render a subject ineligible for the study at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Cardiovascular Hospital
Seoul
Donghoon Choi, M.D., Ph.D., 82-2-2228-8200, cdhlyj@yuhs.ac
About this study
Official title: 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
- Conditions
- Hypertension
- Being tested
- Group I, Group II
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IDrug
Also called Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)
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
Group IIDrug
Also called Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg
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
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | 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 Receives: Drug: Group I |
| Group II | Active comparator | Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks Receives: Drug: Group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment
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.
Measured: Week 8
Secondary outcomes (3)
Change in siSBP from baseline after 4 weeks of treatment
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.
Measured: Week 4
Change in siDBP from baseline after 4 and 8 weeks of treatment
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.
Measured: Week 4 and Week 8
Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment
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.
Measured: Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start17 Apr 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231982
- Sponsor's protocol ID
- CJ_CCA_401
- Acronym
- MACH
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03231982
- Acronym / sponsor ID
- MACH / CJ_CCA_401
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Group IFixed-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 |
| Group II | Active comparator | Drug: Group IICandesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male and female aged 19 to 75 years
- Diagnosed with essential hypertension
- 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).
- 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.
Key exclusion criteria (27 listed)
- 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).
- Blood pressure taken at screening and randomization is ≥ 180 mmHg for siSBP or ≥ 110 mmHg for siDBP.
- 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.]
- 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)
- Diagnosis of type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or with HbA1c > 9%)
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 |
|---|---|---|
| Group IAlso: Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)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 | Drug | Group I |
| Group IIAlso: Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mgAtacan 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 | Drug | Group II |
Primary outcome
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment
Time frame: 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.
3 secondary outcomes
Change in siSBP from baseline after 4 weeks of treatment
Time frame: Week 4
Change in siDBP from baseline after 4 and 8 weeks of treatment
Time frame: Week 4 and Week 8
Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment
Time frame: Week8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group I and Group II in people with Hypertension, 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?
The sponsor lists 6 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 16 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SangJun Youn, Ph.D. (82-8-6477-0240, sangjun.youn@cj.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment (time frame: Week 8). 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 16 Oct 2018.