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Essential HypertensionPhase 2NCT02944734

Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

A Phase 2 study testing Candesartan Cilexetil 8mg, Candesartan Cilexetil 16mg and Amlodipine 5mg in people with Essential Hypertension, run by Shin Poong Pharmaceutical Co. Ltd. at 23 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

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 years and older
Conditions the study is for
Essential Hypertension
What is being tested?
Candesartan Cilexetil 8mg, Candesartan Cilexetil 16mg and Amlodipine 5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
23 sitesSouth Korea
Study dates
Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients greater than or equal to 19 years of age
  • Subject who was diagnosed with essential hypertension or after administer the antihypertensive drug (Subject who may temporarily suspend antihypertensive treatment based on doctor's decision)
  • Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form

Who cannot join

  • Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
  • Subject with difference of the blood pressure of over 20 mmHg for SBP or 10 mmHg for diastolic blood pressure (DSP) between three consecutive measurements in a selected arm during the screening visit
  • Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
  • Symptomatic orthostatic hypotension
  • Severe heart failure( New York Heart Association(NYHA) Class III/IV)
  • Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
Show all 26Show fewer
  • History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
  • Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c > 9.0%)
  • Subject with Haemodynamic disturbance, heart valve disease with structural defects
  • Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
  • Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
  • Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • Chronic inflammatory disease requiring continuous anti-inflammatory treatment
  • Clinically significant Renal or liver impairment, or laboratory abnormalities such as Ccr: below 30ml/min or Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 x Upper Limit Normal (ULN)
  • Hypokalaemia(Serum potassium < 3.5 mmol/L) or hyperkalaemia(Serum potassium > 5.5 mmol/L)
  • Subject with gastrointestinal disease(such as Crohn's disease, gastric ulcer, acute or chronic pancreatitis) or history of gastrointestinal surgery(not including appendectomy or hernia surgery) that might significantly alter the absorption of the drug
  • history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
  • Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
  • Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
  • history of malignant tumors within the past 5 years
  • history of alcohol or drug abuse
  • Pregnant women and lactating mothers
  • Women who is planning to be pregnant during or 2 months after the study, or women or men who are not using medically acceptable methods of contraception *
  • progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.
  • Use of other investigational products within the past 1 month
  • Subject who are judged by the investigator unsuitable to participate in the study

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

South Korea23 sites

  • Inje University Busan Paik Hospital

    Busanjin-gu, Busan

  • Ulsan University Hospital

    Dong-gu, Ulsan

  • Chonnam National University Hospital

    Dong-Gu, Gwangju

  • Catholic University of Korea St. Paul's Hospital

    Dongdaemun-gu, Seoul

  • KyungHee University Medical Center

    Dongdaemun-gu, Seoul

  • Hallym University Kangdong Sacred Heart Hospital

    Gangdong-gu, Seoul

  • VHS( Veterans Medical Service) Medical Center

    Gangdong-gu, Seoul

  • Kyung Hee University Hospital at Gangdong

    Gangdong-Gu, Seoul

  • Konkuk University Medical Center

    Gwangjin-gu, Seoul

  • Dongguk University Ilsan Hospital

    Ilsandong-gu, Goyang-si, Gyeoggi-do

  • Seoul National University Hospital

    Jongro-gu, Seoul

  • Keimyung University Dongsan Medical Center

    Joong-gu, Daegu

  • Kyungpook National University Hospital

    Joong-gu, Daegu

  • Daegu Catholic University Medical Center

    Nam- Gu, Daegu

  • Gachon University Gil Hospital

    Namdong-gu, Incheon

  • Pusan National University Hospital

    Seo-gu, Busan

  • Catholic University of Korea Seoul St. Mary's Hospital

    Seocho-Gu, Seoul

  • Korea University Anam Hospital

    Seongbuk-Gu, Seoul

  • St. Carollo General Hospital

    Suncheon-si, Jeollanam-do

  • Catholic University of Korea Uijeongbu St. Mary's hospital

    Uijeongbu-si, Gyeoggi-do

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do

  • Catholic University of Korea Bucheon St. Mary's Hospital

    Wonmi-gu, Bucheon

  • Catholic University of Korea Yeouido St. Mary's Hospital

    Yeongdeungpo-gu, Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding 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
Candesartan Cilexetil 8mg, Candesartan Cilexetil 16mg, Amlodipine 5mg, Amlodipine 10mg
Keywords
Candesartan, Amlodipine, Hypertension, Vascular Diseases, Cardiovascular Diseases, Antihypertensive Agents, Vasodilator Agents, Angiotensin II Type 1 Receptor Blockers, Angiotensin Receptor Antagonists, Calcium Channel Blockers
Medical subject headings
Essential Hypertension, Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

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

  • Candesartan Cilexetil 8mgDrug

    Also called Atacand 8mg

    Candesartan Cilexetil 8mg Daily oral administration for 8 weeks

  • Candesartan Cilexetil 16mgDrug

    Also called Atacand 16mg

    Candesartan Cilexetil 16mg Daily oral administration for 8 weeks

  • Amlodipine 5mgDrug

    Also called Norvasc 5mg

    Amlodipine 5mg Daily oral administration for 8 weeks

  • Amlodipine 10mgDrug

    Also called Norvasc 10mg

    Amlodipine 10mg Daily oral administration for 8 weeks

Study groups in NCT02944734
Study groupRoleWhat they receive
Candesartan Cilexetil (CC) 8mgExperimentalCandesartan Cilexetil 8mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 8mg
CC 16mgExperimentalCandesartan Cilexetil 16mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 16mg
Amlodipine(AML) 5mgExperimentalAmlodipine 5mg, once a day for 8 weeks
Receives: Drug: Amlodipine 5mg
AML 10mgExperimentalAmlodipine 10mg, once a day for 8 weeks
Receives: Drug: Amlodipine 10mg
CC 8mg / AML 5mgExperimentalCandesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 8mg; Drug: Amlodipine 5mg
CC 8mg / AML 10mgExperimentalCandesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 8mg; Drug: Amlodipine 10mg
CC 16mg / AML 5mgExperimentalCandesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 16mg; Drug: Amlodipine 5mg
CC 16mg / AML 10mgExperimentalCandesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
Receives: Drug: Candesartan Cilexetil 16mg; Drug: Amlodipine 10mg

What is being measured

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

  1. Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline

    Measured: Week 8

Secondary outcomes (4)

  1. Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline

    Measured: Week 4

  2. Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline

    Measured: Week 4 and 8

  3. Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg

    Joint National Committee VII Guideline Treatment goal: < 140/90 mmHg (< 130/80 mmHg, diabetic or chronic renal failure patient)

    Measured: Week 4 and 8

  4. Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg

    Measured: Week 4 and 8

Timeline

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

  1. First posted26 Oct 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2015
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944734
Sponsor's protocol ID
SP-AC-002
Status last verified
Nov 2016
First submitted
24 Oct 2016
Last updated
22 Nov 2016
Results posted
No

Publications

  • Sohn IS, Kim CJ, Ahn T, Youn HJ, Jeon HK, Ihm SH, Cho EJ, Chung WB, Chae SC, Kim WS, Nam CW, Park SM, Choi JY, Kim YK, Hong TJ, Lee HY, Cho JH, Shin ES, Yoon JH, Yang TH, Jeong MH, Lee JH, Park JI. Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial. Clin Ther. 2017 Aug;39(8):1628-1638. doi: 10.1016/j.clinthera.2017.06.014. Epub 2017 Jul 19.

    PubMed 28734660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Candesartan Cilexetil 8mg, Candesartan Cilexetil 16mg and Amlodipine 5mg in people with Essential Hypertension, run by Shin Poong Pharmaceutical Co. Ltd. at 23 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 26 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

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 mean sitting Diastolic Blood Pressure (msDBP) 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 NCT02944734, which also lists 1 linked publication.

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 22 Nov 2016.

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Clinical Trial NCT02944734 | AzTrials