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Essential HypertensionPhase 2NCT02059616

A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension

A Phase 2 study testing Amlodipine 5mg, Amlodipine 10mg and Candesartan Cilexetil 8mg in people with Essential Hypertension, run by HK inno.N Corporation at 20 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension. 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?
Amlodipine 5mg, Amlodipine 10mg and Candesartan Cilexetil 8mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
20 sitesSouth Korea
Study dates
Feb 2014to Dec 2015
Phase
Phase 2
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 mild-to-moderate uncomplicated 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 with severe hypertension (siDBP ≥ 115 mmHg or siSBP ≥ 185 mmHg)
  • Subject with difference in the mean blood pressure of over 10mmHg for siDBP or 20mmHg 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 hypertension, adrenal medullary and cortical hyperfunction, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, 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 supine position)
  • Subject with Type 1 diabetes mellitus OR Type 2 diabetes mellitus with poor glucose control (defined as subject on insulin 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 III-IV), ischemic heart disease within the past 6 months (unstable angina, myocardial infarction), peripheral vascular disease, history of Percutaneous Transluminal Coronary Angioplasty or Coronary Artery Bypass Grafting)
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  • 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 severe cerebrovascular disease (history of stroke, cerebral infarction, or cerebral hemorrhage within the past 6 months)
  • Subject with or with a history of wasting disease, autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus), 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 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 > 5.5 mmol/L
  • Subject with any surgical or medical condition of the gastrointestinal tract that might significantly 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 years (except for localized basal cell carcinoma of the skin)
  • Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy
  • Subject with chronic kidney disease on dialysis
  • Subject with cardiogenic shock
  • 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, lactating mothers, 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 contraceptive, 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 Visit 1 and maintain acceptable methods of contraception throughout the study. Periodic 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 judged unsuitable to participate in the study in the opinion of the investigator

Trial locations and contacts

20 sites in 1 country.

Geun Seog Song, PhD contact

82-2-6740-2440

kssong1212@cj.net

Eun Ji Kim contact

82-2-6740-2443

keunji@cj.net

20 sites in 1 country

South Korea20 sites, 20 recruiting

  • Seoul National University Bundang Hospital

    Bundang

    Recruiting

  • Dong-A University Hospital

    Busan

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Recruiting

  • Konyang University Hospital

    Daejeon

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Recruiting

  • Inha University Hospital

    Incheon

    Recruiting

  • Hallym University Sacred Heart hospital

    Kyungki-do

    Recruiting

  • Inje University Haeundae Baik Hospital

    Pusan

    Recruiting

  • Pusan National University Hospital

    Pusan

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Recruiting

  • Seoul Medical Center

    Seoul

    Recruiting

  • Seoul St. Mary's hospital

    Seoul

    Recruiting

  • Severance Hospital

    Seoul

    Recruiting

  • Soonchunhyang University Hospital

    Seoul

    Recruiting

  • Yonsei University Gangnam Severance Hospital

    Seoul

    Recruiting

  • Ajou University Hospital

    Suwon

    Seung-Jea Tahk

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju

    Recruiting

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection in Patients With Essential Hypertension

The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.

Being tested
Amlodipine 5mg, Amlodipine 10mg, Candesartan Cilexetil 8mg, 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.

  • Amlodipine 5mgDrug

    Also called Norvasc 5mg

    Daily oral administration for 8 weeks

  • Amlodipine 10mgDrug

    Also called Norvasc 10mg

    Daily oral administration for 8 weeks

  • Candesartan Cilexetil 8mgDrug

    Also called Atacand 8mg

    Daily oral administration for 8 weeks

  • Candesartan cilexetil 16mgDrug

    Also called Atacand 16mg

    Daily oral administration for 8 weeks

Study groups in NCT02059616
Study groupRoleWhat they receive
AML 5mgExperimentalAmlodipine 5 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 5mg
AML 10mgExperimentalAmlodipine 10 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 10mg
CC 8mgExperimentalCandesartan Cilexetil 8 mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 8mg
CC 16mgExperimentalCandesartan Cilexetil 16 mg, once a day for 8 weeks
Receives: Drug: Candesartan cilexetil 16mg
AML 5mg/CC 8mgExperimentalAmlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 5mg; Drug: Candesartan Cilexetil 8mg
AML 5mg/CC16mgExperimentalAmlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 5mg; Drug: Candesartan cilexetil 16mg
AML 10mg/CC 8mgExperimentalAmlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 10mg; Drug: Candesartan Cilexetil 8mg
AML 10mg/CC 16mgExperimentalAmlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Receives: Drug: Amlodipine 10mg; Drug: 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 sitting Systolic Blood Pressure (siSBP) at week 4 and 8

    Measured: Week 4 and 8

  2. Change in siDBP at week 4

    Measured: Week 4

  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 < 120 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 posted11 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionDec 2015 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059616
Sponsor's protocol ID
CJ_CCA_201
Status last verified
Apr 2014
First submitted
10 Feb 2014
Last updated
30 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlodipine 5mg, Amlodipine 10mg and Candesartan Cilexetil 8mg in people with Essential Hypertension, run by HK inno.N Corporation at 20 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: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Geun Seog Song, PhD (82-2-6740-2440, kssong1212@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 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 NCT02059616.

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 30 Apr 2014.

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