Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Study Overview
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Brief Summary
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To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.

Official Title
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A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Telmisartan 80mg
* Drug: Rosuvastatin 20mg
* Drug: Rosuvastatin 10mg
* Drug: Placebo(for Telmisartan 80mg)
* Drug: Placebo(for Rosuvastatin 20mg)
* Drug: Placebo(for Rosuvastatin 10mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Men and women >18 years of age Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent Exclusion Criteria: Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,. Other exclusions applied

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan 80mg & Rosuvastatin 20mg<br>PO, Once Daily, 8 weeks | Drug: Telmisartan 80mg<br> <br> Drug: Rosuvastatin 20mg<br> <br> Drug: Placebo(for Rosuvastatin 10mg)<br> <br> |
| Experimental: Telmisartan 80mg & Rosuvastatin 10mg<br>PO, Once Daily, 8weeks | Drug: Telmisartan 80mg<br> <br> Drug: Rosuvastatin 10mg<br> <br> Drug: Placebo(for Rosuvastatin 20mg)<br> <br> |
| Active Comparator: Telmisartan placebo & Rosuvastatin 20mg<br>PO, Once Daily, 8 weeks | Drug: Rosuvastatin 20mg<br> <br> Drug: Placebo(for Telmisartan 80mg)<br> <br> Drug: Placebo(for Rosuvastatin 10mg)<br> <br> |
| Active Comparator: Telmisartan Placebo & Rosuvastatin 10mg<br>PO, Once Daily, 8 weeks | Drug: Rosuvastatin 10mg<br> <br> Drug: Placebo(for Telmisartan 80mg)<br> <br> Drug: Placebo(for Rosuvastatin 20mg)<br> <br> |
| Active Comparator: Telmisartan 80mg & Rosuvastatin placebo<br>PO, Once Daily, 8 weeks | Drug: Telmisartan 80mg<br> <br> Drug: Placebo(for Telmisartan 80mg)<br> <br> Drug: Placebo(for Rosuvastatin 20mg)<br> <br> |
| Placebo Comparator: Telmisartan placebo & Rosuvastatin placebo<br>PO, Once Daily, 8 weeks | Drug: Placebo(for Telmisartan 80mg)<br> <br> Drug: Placebo(for Rosuvastatin 20mg)<br> <br> Drug: Placebo(for Rosuvastatin 10mg)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Change in seated diastolicblood pressure at 8 weeks compared to the base value |  | at the 8 weeks | 
| Change in LDL-Cat 8 weeks compared to the base value (% change) |  | at the 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in seateddiastolic blood pressure |  | at 2,4 8 weeks | 
| Change in seated systolic blood pressure |  | at 2,4,8weeks | 
| Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)] |  | at 2, 4 and 8 weeks | 
| Change in LDL-Cat compared to the base value (% change) |  | 2, 4 and 8 weeks | 
| Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change) |  | at 2, 4 and 8 weeks | 
| Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL) |  | at 2, 4 and 8 weeks |