Status:
COMPLETED
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Lead Sponsor:
LG Life Sciences
Conditions:
Hypertension,
Hyperlipidemia
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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 )
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01918332
Start Date
April 1 2012
End Date
March 1 2013
Last Update
December 15 2014
Active Locations (1)
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1
Yonsei University Health System Severance Hospital
Seoul, South Korea