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AzTrials

Essential HypertensionPhase 3NCT02368652

A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy

A Phase 3 study testing Candesartan cilexetil 16mg and Amlodipine 10mg, Candesartan cilexetil 16mg in people with Essential Hypertension, run by HK inno.N Corporation at 19 sites 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

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by candesartan cilexetil monotherapy. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Essential Hypertension
What is being tested?
Candesartan cilexetil 16mg and Amlodipine 10mg, Candesartan cilexetil 16mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
19 sitesSouth Korea
Study dates
Dec 2014to Nov 2015
Phase
Phase 3
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

  • Male or female aged ≥ 19 and ≤ 75 years old
  • Subject with essential hypertension
  • Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial

Who cannot join

  • Subject who is siDBP ≥ 120 mmHg or siSBP ≥ 200 mmHg at Visit 1 (screening)
  • Subject with difference in the mean blood pressure of over 10 mmHg for siDBP or 20 mmHg for siSBP between both arms at the screening visit
  • Subject with known or suspected secondary hypertension [Including but not limited to any of the following: renovascular diseases, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.]
  • Subject with symptomatic orthostatic hypotension(a sudden fall in siDBP of at least 10 mmHg or siSBP of at least 20 mmHg after standing compared with blood pressure from the sitting or supin position)
  • Subject with type 1 or type 2 diabetes mellitus with poor glucose control (defined as subject on inculin treatment, with HbA1c > 9.0% or with a modification in the oral anti-hyperglycemic medication regiment within the past 12 weeks prior to visit 1)
  • Subject with severe heart disease(congestive heart failure(NYHA class 3 or 4), ischemic heart disease within the past 6 months(unstable angina, myocardial infarction), peripheral blood vascula disease, history of Percutaneous Transluminal Coronary Angioplasty or coronary artery bypass grafting)
Show all 27Show fewer
  • Subject with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia
  • Subject with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve
  • Subject with cardiogenic shock
  • Subject with severe cerebrovascular disease (history of stroke, cerebral infraction, or cerebral hemorrhage within the past 6 months)
  • Subject with a history of or ongoing wasting disease, autoimmune diseases(rheumatoid arthritis, systemic lupus erythematosus, etc.) or connective tissue disease
  • Subject with known moderate or malignant retinopathy (history of retinal signs of hemorrhage, visual impairment, retinal microaneurysm etc. within the past 6 months)
  • Subject with any surgical or medical condition of the gastrointestinal tract that might sugnificantly alter the absorption, distribution, metabolism or excretion of the drug
  • Subject with a history of malignant tumors including leukemia and lymphoma within the past 5 yesrs(except for localized basal cell carcinoma of the skin)
  • Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy
  • Subject with chronic kidney disase on dialysis
  • Subject with the following clinically significant laboratory abnormalities:
  • AST or ALT > 3 x Upper Limit Normal(ULN)
  • Serum Creatinine > 1.5 ULN
  • Serum potassium < 3.5 mmol/L or > 5.5mmol/L
  • Subject requiring concomitant use of other antihypertensive or contraindicated drugs during the entire study period
  • Subject with known or suspected contraindications, including history of allergy or hypersensitivity to ARB or dihydropyridine derivatives
  • Subject who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARB
  • Pregnant women or lactating mother, women suspected of being pregnant, women who wish to be pregnant during the study or women of child-bearing potential who are not using medically acceptable methods of contraception (oral contraceptinve, intra-uterine device, condom, etc.), except for women with surgical sterilization. Pre-menopausal women who are not surgically sterilized must have a negative pregnancy test result at Visit1 and maintain acceptable methods of contraception throughout the study. preiodic abstinence (eg. symptothermal, calendar, post-ovulation methods), or hormonal contraceptive are not acceptable methods of contraception
  • History of drug or alcohol abuse within the past 1 year
  • Use of other investigational products within the past 4 weeks
  • Subject who are jdged unsuitable to participate in the study in the opinion of the investigator

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

South Korea19 sites

  • Hallym University Sungsim Hospital

    Anyang-si

  • Inje University Busan Baik Hospital

    Busan

  • Inje University Haeundae Baik Hospital

    Busan

  • Yeungnam University Medical Center

    Daegu

  • Chonnam National University Hospital

    Gwangju

  • Inje University Ilsan Baik Hospital

    Ilsan

  • Inha University Hospital

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Ewha Womans University Mokdong Hospital

    Seoul

  • Gangbuk Samsung Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Seoul Medical Center

    Seoul

  • Seoul St. Mary's Hospital Catholic University

    Seoul

  • Soonchunhyang University Hospital

    Seoul

  • Yonsei University Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multi-center, Phase III Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil Combination in Patients With Essential Hypertension Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by candesartan cilexetil monotherapy.

Being tested
Candesartan cilexetil 16mg, Amlodipine 10mg, Candesartan cilexetil 16mg
Medical subject headings
Essential Hypertension

What participants receive

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

  • Candesartan cilexetil 16mgDrug

    Also called Atacand 16mg

    Daily oral administration for 8 weeks

  • Amlodipine 10mg, Candesartan cilexetil 16mgDrug

    Also called Norvasc 10mg, Atacand 16mg

    Daily oral administration for 8 weeks

Study groups in NCT02368652
Study groupRoleWhat they receive
CC 16mgExperimentalCandesartan ceilexetil 16mg, once a day for 8 weeks
Receives: Drug: Candesartan cilexetil 16mg
AML 10mg / CC 16mgExperimentalAmlodipine 10mg and Candesartan ceilexetil 16mg, once a day for 8 weeks
Receives: Drug: Amlodipine 10mg, Candesartan cilexetil 16mg

What is being measured

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

  1. Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline

    Measured: Week 8

Secondary outcomes (4)

  1. Change in siDBP at week 4

    Measured: Week 4

  2. Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8

    Measured: Week 4 and 8

  3. Proportion of patients achieving ΔsiDBP ≥ 10 mmHg and ΔsiSBP ≥ 20 mmHg after 8 weeks

    Measured: Week 8

  4. Proportion of patients achieving siDBP < 90 mmHg and siSBP < 140 mmHg after 8 weeks

    Measured: Week 8

Timeline

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

  1. First posted23 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02368652
Sponsor's protocol ID
CJ_CCA_301A
Status last verified
May 2023
First submitted
16 Feb 2015
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Candesartan cilexetil 16mg and Amlodipine 10mg, Candesartan cilexetil 16mg in people with Essential Hypertension, run by HK inno.N Corporation at 19 sites 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 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Diastolic Blood Pressure (siDBP) at week 8 compared to baseline (time frame: Week 8). 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 NCT02368652.

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 6 May 2023.

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