Essential Hypertension
Conditions
Brief summary
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination
Interventions
DRUGTelmisartan/Amlodipine+Hydrochlorothiazide
Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD
Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD
DRUGPlacebo for Hydrochlorothiazide
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 19 years old or above Koreans living in Korea 2. Patients with uncontrolled essential hypertension at screening time(Visit 1) * Naïve: 160 mmHg ≤ sitSBP \< 200 mmHg * Use antihypertensive drugs:140 mmHg ≤ sitSBP \< 200 mmHg 3. Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2) \- 140 mmHg ≤ sitSBP \< 200 mmHg 4. Patients who agreed to participate in the trial
Exclusion criteria
1. Test results showing the following values at screening time(Visit 1) * The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement * screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg 2. Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma) 3. -Patients with congestive heart failure(NYHA class III\ IV) * Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry * Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia 4. Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry 5. Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c \> 9% 6. Patients who have history of severe or malignant retinopathy within 6 months prior to study entry 7. Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :\> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT \> 2.5 times of upper limit of normal range) 8. Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators) 9. Patients who should be administered medications prohibited for concomitant use during study period 10. Patients who are dependent on drugs or alcohol 11. Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion 12. Patients with hypersensitivity to the components of investigational drug. 13. Patients with hypersensitivity to Sulfonamide 14. Patients with anuria 15. Patients with hypercalcemia, hyponatremia/hypokalemia 16. Patients with Addison's disease 17. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 18. Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy 19. History of malignant tumor including leukemia, lymphoma within 5 years 20. Patients taking other clinical trial drugs within 30 days from the time of visit for screening 21. Pregnancy, breast-feeding, or child-bearing potential Patients 22. Patients who are judged unsuitable to participate in this study by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of sitting systolic blood pressure | From baseline at week 8 |
Secondary
| Measure | Time frame |
|---|---|
| The change of sitting systolic blood pressure | From baseline at week 2 |
| The change of sitting diastolic blood pressure | From baseline at week 2 and 8 |
| The ratio of subjects who get normalized blood pressure | at week 2 and 8 |
| Response Rate | at week 2 and 8 |
Countries
South Korea
Outcome results
None listed