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To Evaluate Safety and Effectiveness of RovatitanTab.

A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04398771
Enrollment
1000
Registered
2020-05-21
Start date
2020-09-01
Completion date
2022-05-31
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias, Hypertension

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

Interventions

DRUGRosuvastatin/Valsartan

Rovatitan QD for 12 weeks

Sponsors

LG Chem
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The ratio of patients who reach the target BP12weeksSBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years)
The ratio of patients who reach the target LDLcholesterol12weekstarget LDL refered to Hyperlipidemia pharmacotherapy

Secondary

MeasureTime frameDescription
The ratio of patients who reach the target BP and LDL-c12weeksSBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years), target LDL

Contacts

Primary Contactsongyi Park
songyi-park@lgchem.com=82-2-6987-4195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026