Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.

Official Title
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A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia

Conditions
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Hypertension,, Hyperlipidemia

Intervention / Treatment
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* Drug: Valsartan 160mg
* Drug: Rosuvastatin 20mg
* Drug: Valsartan 160mg placebo
* Drug: Rosuvastatin 20mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 20-80 years who has hypertension and hyperlipidemia Patient who has a Hypertension Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004) Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study Exclusion Criteria: If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C>250mg/dL , or TG≥ 400mg/dL If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

Ages Eligible for Study
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Minimum Age: 20 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan 160mg, Rosuvastatin 20mg<br>Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. | Drug: Valsartan 160mg<br> <br> * Other names: Diovan;Drug: Rosuvastatin 20mg<br> <br> * Other names: Crestor;|
| Active Comparator: Valsartan 160mg, Rosuvastatin 20mg placebo<br>Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. | Drug: Valsartan 160mg<br> <br> * Other names: Diovan;Drug: Rosuvastatin 20mg placebo<br> <br> |
| Active Comparator: Valsartan 160mg placebo, Rosuvastatin 20mg<br>Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. | Drug: Rosuvastatin 20mg<br> <br> * Other names: Crestor;Drug: Valsartan 160mg placebo<br> <br> |
| Placebo Comparator: Placebo<br>Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. | Drug: Valsartan 160mg placebo<br> <br> Drug: Rosuvastatin 20mg placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitDBP Changes at Week 8 From Baseline | sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline | 8 weeks | 
| LDL-C Percentage Changes at Week 8 From Baseline | LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline | 8 weeks |