Hypertension With Hyperlipidemia
Conditions
Brief summary
A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia
Interventions
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 2. Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL) 3. Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator 4. Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure \>140mmHg 5. Test results showing the following values at screening time (Visit 2) : 100\< LDL-Cholesterol \<250 6. Patients who agreed to participate in the trial
Exclusion criteria
1. Severe hypertension patients(systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg) -The change of mean sit systolic blood pressure ≥ 20 mmHg or sit diastolic blood pressure ≥ 10 mmHg on target arm between 1st and 2nd measurement 2. LDL-Cholesterol \> 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1) 3. Patients with postural hypotension who have sign and symptom 4. Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases) 5. Patients with congestive heart failure(New York Heart Association class III\ IV) 6. Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months 7. Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia 8. Causes of hemodynamic disorder or structural heart defect such as valvular heart disease 9. Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry 10. Patients with primary aldosteronism 11. Patients with severe ocular disorders 12. Patients with autoimmune disease 13. Patients with any chronic inflammation disease needed to chronic inflammation therapy 14. Patients with uncontrolled diabetes Mellitus with HbA1c \> 9% or thyroid diseases(TSH ≥ 1.5 X ULN) 15. Patients who have a history of myopathy or rhabdomyolysis 16. Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK) 17. History of malignant tumor including leukemia, lymphoma within 5 years 18. Patients with one kidney 19. Patients with biliary obstructive disorder 20. Patients with clinically significant electrolyte disturbance 21. Continued serum potassium concentration abnormal status (\<3.5mEq/L or \>5.5mEq/L) 22. Patients with sodium ion or body fluid is depleted and not able to correct 23. Patients with clinically significant liver/renal disease 24. Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery 25. Patients who are dependent on drugs or alcohol 26. Pregnancy, breast-feeding, or child-bearing potential Patients 27. Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers 28. Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs 29. Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate 30. Patients who are unable to stop taking prohibited drugs to combination during study period 31. Patients who have galactose intolerance 32. Patients taking other clinical trial drugs within 30 days from the time of visit for screening 33. Patients that is not eligible to participate at the discretion of study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of change in LDL-Cholesterol | From baseline at week 8 | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine |
| The change of sitting systolic blood pressure | From baseline at week 8 | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin |
Secondary
| Measure | Time frame |
|---|---|
| The change of HDL-Cholesterol/LDL-Cholesterol ratio | From baseline at week 4 and 8 |
| The change of total cholesterol/HDL-Cholesterol ratio | From baseline at week 4 and 8 |
| Percentage of change in LDL-Cholesterol | From baseline at week 4 |
| The change of sitting diastolic blood pressure | From baseline at week 4 and 8 |
| Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline | From baseline at week 4 and 8 |
| Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline | From baseline at week 4 and 8 |
| Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B | From baseline at week 4 and 8 |
Countries
South Korea
Outcome results
None listed