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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02944734
Other study ID # SP-AC-002
Secondary ID
Status Completed
Phase Phase 2
First received October 24, 2016
Last updated November 21, 2016
Start date September 2014
Est. completion date December 2015

Study information

Verified date November 2016
Source Shin Poong Pharmaceutical Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Korea Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 392
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks

Locations

Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busanjin-gu Busan
Korea, Republic of Chonnam National University Hospital Dong-Gu Gwangju
Korea, Republic of Ulsan University Hospital Dong-gu Ulsan
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 Dongguk University Ilsan Hospital Ilsandong-gu Goyang-si, Gyeoggi-do
Korea, Republic of Seoul National University Hospital Jongro-gu Seoul
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 Gachon University Gil Hospital Namdong-gu Incheon
Korea, Republic of Pusan National University Hospital Seo-gu Busan
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 St. Carollo General Hospital Suncheon-si Jeollanam-do
Korea, Republic of Catholic University of Korea Uijeongbu St. Mary's hospital Uijeongbu-si Gyeoggi-do
Korea, Republic of Wonju Severance Christian Hospital Wonju Kangwon-Do
Korea, Republic of Catholic University of Korea Bucheon St. Mary's Hospital Wonmi-gu Bucheon
Korea, Republic of Catholic University of Korea Yeouido St. Mary's Hospital Yeongdeungpo-gu Seoul

Sponsors (1)

Lead Sponsor Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline Week 8 No
Secondary Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline Week 4 No
Secondary Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline Week 4 and 8 No
Secondary 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) Week 4 and 8 No
Secondary Blood Pressure Response rate at week 4 and 8: msSBP reduction = 20 mmHg and msDBP reduction = 10 mmHg Week 4 and 8 No
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