CClinicalTrials.gg
CompletedNCT02944734Updated Nov 22, 2016

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 interventional study of Candesartan Cilexetil 8mg and Candesartan Cilexetil 16mg in Essential Hypertension, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 23 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Candesartan
  • Amlodipine
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Antihypertensive Agents
  • Vasodilator Agents
  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin Receptor Antagonists
  • Calcium Channel Blockers
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 392 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female patients greater than or equal to 19 years of age
  2. 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)
  3. Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
  2. 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
  3. Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
  4. Symptomatic orthostatic hypotension
  5. Severe heart failure( New York Heart Association(NYHA) Class III/IV)
  6. Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
  7. History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
  8. Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c > 9.0%)
  9. Subject with Haemodynamic disturbance, heart valve disease with structural defects
  10. Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
  11. Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
  12. Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  13. Chronic inflammatory disease requiring continuous anti-inflammatory treatment
  14. 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)
  15. Hypokalaemia(Serum potassium \< 3.5 mmol/L) or hyperkalaemia(Serum potassium > 5.5 mmol/L)
  16. 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
  17. history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
  18. Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
  19. Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
  20. history of malignant tumors within the past 5 years
  21. history of alcohol or drug abuse
  22. Pregnant women and lactating mothers
  23. 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.

  24. Use of other investigational products within the past 1 month
  25. Subject who are judged by the investigator unsuitable to participate in the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
392 participants (actual)

Study arms

  • Experimental
    Candesartan Cilexetil (CC) 8mg

    Candesartan Cilexetil 8mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 8mg

  • Experimental
    CC 16mg

    Candesartan Cilexetil 16mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 16mg

  • Experimental
    Amlodipine(AML) 5mg

    Amlodipine 5mg, once a day for 8 weeks

    Drug: Amlodipine 5mg

  • Experimental
    AML 10mg

    Amlodipine 10mg, once a day for 8 weeks

    Drug: Amlodipine 10mg

  • Experimental
    CC 8mg / AML 5mg

    Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 8mg · Drug: Amlodipine 5mg

  • Experimental
    CC 8mg / AML 10mg

    Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 8mg · Drug: Amlodipine 10mg

  • Experimental
    CC 16mg / AML 5mg

    Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 16mg · Drug: Amlodipine 5mg

  • Experimental
    CC 16mg / AML 10mg

    Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks

    Drug: Candesartan Cilexetil 16mg · Drug: Amlodipine 10mg

Interventions

  • DrugCandesartan Cilexetil 8mg

    Candesartan Cilexetil 8mg Daily oral administration for 8 weeks

    Also known as: Atacand 8mg

  • DrugCandesartan Cilexetil 16mg

    Candesartan Cilexetil 16mg Daily oral administration for 8 weeks

    Also known as: Atacand 16mg

  • DrugAmlodipine 5mg

    Amlodipine 5mg Daily oral administration for 8 weeks

    Also known as: Norvasc 5mg

  • DrugAmlodipine 10mg

    Amlodipine 10mg Daily oral administration for 8 weeks

    Also known as: Norvasc 10mg

06

What researchers measure

Primary outcomes

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

    Time frame: Week 8

Secondary outcomes

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

    Time frame: Week 4

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

    Time frame: 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)

    Time frame: Week 4 and 8

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

    Time frame: Week 4 and 8

07

Study locations

23 sites
  • Catholic University of Korea Bucheon St. Mary's Hospital
    Wonmi-gu, Bucheon, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busanjin-gu, Busan, Korea, Republic of
  • Pusan National University Hospital
    Seo-gu, Busan, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Joong-gu, Daegu, Korea, Republic of
  • Kyungpook National University Hospital
    Joong-gu, Daegu, Korea, Republic of
  • Daegu Catholic University Medical Center
    Nam- gu, Daegu, Korea, Republic of
  • Dongguk University Ilsan Hospital
    Ilsandong-gu, Goyang-si, Gyeoggi-do, Korea, Republic of
  • Chonnam National University Hospital
    Dong-Gu, Gwangju, Korea, Republic of
  • Catholic University of Korea Uijeongbu St. Mary's hospital
    Uijeongbu-si, Gyeoggi-do, Korea, Republic of
  • Gachon University Gil Hospital
    Namdong-gu, Incheon, Korea, Republic of
  • St. Carollo General Hospital
    Suncheon-si, Jeollanam-do, Korea, Republic of
  • Wonju Severance Christian Hospital
    Wonju, Kangwon-Do, Korea, Republic of
  • Catholic University of Korea St. Paul's Hospital
    Dongdaemun-gu, Seoul, Korea, Republic of
  • KyungHee University Medical Center
    Dongdaemun-gu, Seoul, Korea, Republic of
  • Hallym University Kangdong Sacred Heart Hospital
    Gangdong-gu, Seoul, Korea, Republic of
  • Kyung Hee University Hospital at Gangdong
    Gangdong-Gu, Seoul, Korea, Republic of
  • VHS( Veterans Medical Service) Medical Center
    Gangdong-gu, Seoul, Korea, Republic of
  • Konkuk University Medical Center
    Gwangjin-gu, Seoul, Korea, Republic of
  • Seoul National University Hospital
    Jongro-gu, Seoul, Korea, Republic of
  • Catholic University of Korea Seoul St. Mary's Hospital
    Seocho-Gu, Seoul, Korea, Republic of
  • Korea University Anam Hospital
    Seongbuk-Gu, Seoul, Korea, Republic of
  • Catholic University of Korea Yeouido St. Mary's Hospital
    Yeongdeungpo-gu, Seoul, Korea, Republic of
  • Ulsan University Hospital
    Dong-gu, Ulsan, Korea, Republic of
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02944734
Lead sponsor
Shin Poong Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Oct 26, 2016
Start date
Sep 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Nov 22, 2016

Study contacts

Chong-Jin Kim
study director · KyungHee University Hospital at Gangdong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion