Essential Hypertension
Conditions
Keywords
Candesartan, Amlodipine, Hypertension, Vascular Diseases, Cardiovascular Diseases, Antihypertensive Agents, Vasodilator Agents, Angiotensin II Type 1 Receptor Blockers, Angiotensin Receptor Antagonists, Calcium Channel Blockers
Brief 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.
Interventions
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
DRUGAmlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
DRUGAmlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Sponsors
Shin Poong Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline | Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline | Week 4 | — |
| Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline | Week 4 and 8 | — |
| Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg | Week 4 and 8 | Joint National Committee VII Guideline Treatment goal: \< 140/90 mmHg (\< 130/80 mmHg, diabetic or chronic renal failure patient) |
| Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg | Week 4 and 8 | — |
Countries
South Korea
Outcome results
None listed