To Evaluate Safety and Effectiveness of RovatitanTab.
- Conditions
- HyperlipidemiasHypertension
- Interventions
- Drug: Rosuvastatin/Valsartan
- Registration Number
- NCT04398771
- Lead Sponsor
- LG Chem
- Brief Summary
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia
- Detailed Description
* Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
* Safety: we will collect safety data
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patients who have hypertension and hyperlipidemia and older than 19 years
- Patients who undertstand purpose and method of study, agree with study
Exclusion Criteria
- Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
- Uncontrolled hypertension (SBP>=180mmHg or DBP>=110mmHg)
- Patients who participated another clinical study or observational study 3 months ago.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Rosuvastatin/Valsartan Rovatitan 5/80mg (Rosuvastatin 5mg/Valsartan 80mg) Rovatitan 5/160mg (Rosuvastatin 5mg/Valsartan 160mg) Rovatitan 10/80mg (Rosuvastatin 10mg/Valsartan 80mg) Rovatitan 10/160mg (Rosuvastatin 10mg/Valsartan 160mg) Rovatitan 20/80mg (Rosuvastatin 20mg/Valsartan 80mg) Rovatitan 20/160mg (Rosuvastatin 20mg/Valsartan 160mg)
- Primary Outcome Measures
Name Time Method The ratio of patients who reach the target BP 12weeks SBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years)
The ratio of patients who reach the target LDLcholesterol 12weeks target LDL refered to Hyperlipidemia pharmacotherapy
- Secondary Outcome Measures
Name Time Method The ratio of patients who reach the target BP and LDL-c 12weeks SBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years), target LDL