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
Overview
- Phase
- Phase 3
- Intervention
- Valsartan 160mg
- Conditions
- Hypertension,
- Sponsor
- LG Life Sciences
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- sitDBP Changes at Week 8 From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 )
Arms & Interventions
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Intervention: Valsartan 160mg
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Intervention: Rosuvastatin 20mg
Valsartan 160mg, Rosuvastatin 20mg placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Intervention: Valsartan 160mg
Valsartan 160mg, Rosuvastatin 20mg placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Intervention: Rosuvastatin 20mg placebo
Valsartan 160mg placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Intervention: Rosuvastatin 20mg
Valsartan 160mg placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Intervention: Valsartan 160mg placebo
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Intervention: Valsartan 160mg placebo
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Intervention: Rosuvastatin 20mg placebo
Outcomes
Primary Outcomes
sitDBP Changes at Week 8 From Baseline
Time Frame: 8 weeks
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
LDL-C Percentage Changes at Week 8 From Baseline
Time Frame: 8 weeks
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline