To Evaluate Safety and Effectiveness of RovatitanTab.

LG Chem

Status: Unknown

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: Rosuvastatin/Valsartan

Study type: Observational

Funder types: Industry

Identifiers

NCT04398771

LG-VROS001

Details and patient eligibility

About

To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia

Full description

• Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
• Safety: we will collect safety data

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Treatment

Description:

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)

Treatment:

Drug: Rosuvastatin/Valsartan