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To Evaluate Safety and Effectiveness of RovatitanTab.

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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

Trial contacts and locations

0

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Central trial contact

songyi Park

Data sourced from clinicaltrials.gov

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