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 LDLcholesterol 12weeks target LDL refered to Hyperlipidemia pharmacotherapy
The ratio of patients who reach the target BP 12weeks SBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years)
- 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