Efficacy/Safety of Telmisartan/Amlodipine/Rosuvastatin in Hypertensive Patients With Hyperlipidemia

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypertension With Hyperlipidemia

Intervention / Treatment
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* Drug: Telmisartan/Amlodipine
* Drug: Rosuvastatin
* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years old or above Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL) Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure >140mmHg Test results showing the following values at screening time (Visit 2) : 100< LDL-Cholesterol <250 Patients who agreed to participate in the trial Exclusion Criteria: 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 LDL-Cholesterol > 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1) Patients with postural hypotension who have sign and symptom Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases) Patients with congestive heart failure(New York Heart Association class III IV) Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia Causes of hemodynamic disorder or structural heart defect such as valvular heart disease Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry Patients with primary aldosteronism Patients with severe ocular disorders Patients with autoimmune disease Patients with any chronic inflammation disease needed to chronic inflammation therapy Patients with uncontrolled diabetes Mellitus with HbA1c > 9% or thyroid diseases(TSH ≥ 1.5 X ULN) Patients who have a history of myopathy or rhabdomyolysis Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK) History of malignant tumor including leukemia, lymphoma within 5 years Patients with one kidney Patients with biliary obstructive disorder Patients with clinically significant electrolyte disturbance Continued serum potassium concentration abnormal status (<3.5mEq/L or >5.5mEq/L) Patients with sodium ion or body fluid is depleted and not able to correct Patients with clinically significant liver/renal disease Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery Patients who are dependent on drugs or alcohol Pregnancy, breast-feeding, or child-bearing potential Patients Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate Patients who are unable to stop taking prohibited drugs to combination during study period Patients who have galactose intolerance Patients taking other clinical trial drugs within 30 days from the time of visit for screening Patients that is not eligible to participate at the discretion of study investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan/Amlodipine+Rosuvastatin<br>Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab. | Drug: Telmisartan/Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |
| Active Comparator: Telmisartan/Amlodipine<br>Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab. | Drug: Telmisartan/Amlodipine<br> <br> |
| Active Comparator: Telmisartan +Rosuvastatin<br>Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab. | Drug: Rosuvastatin<br> <br> Drug: Telmisartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in LDL-Cholesterol | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine | From baseline at week 8 | 
| The change of sitting systolic blood pressure | Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin | From baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in LDL-Cholesterol |  | From baseline at week 4 | 
| Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B |  | From baseline at week 4 and 8 | 
| 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 patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline |  | From baseline at week 4 and 8 | 
| 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 |