Clinical trial NCT02738632 (phase 3, status: completed)
Conditions: essential hypertension
ICD codes: I10, O10.02, O10.03, O10.011, O10.012, O10.013, O10.019
Drugs: telmisartan/amlodipine+hydrochlorothiazide, telmisartan/amlodipine, placebo for hydrochlorothiazide
SMILES: CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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