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NCT04398771 Clinical Trial

To Evaluate Safety and Effectiveness of RovatitanTab.

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04398771
Other study ID # LG-VROS001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date May 31, 2022

Study information
Verified date May 2020
Source LG Chem
Contact songyi Park
Phone =82-2-6987-4195
Email songyi-park@lgchem.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

- Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol

- Safety: we will collect safety data

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date May 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin/Valsartan
Rovatitan QD for 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
LG Chem

Outcome
Type Measure Description Time frame Safety issue
Primary The ratio of patients who reach the target BP SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years) 12weeks
Primary The ratio of patients who reach the target LDLcholesterol target LDL refered to Hyperlipidemia pharmacotherapy 12weeks
Secondary The ratio of patients who reach the target BP and LDL-c SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years), target LDL 12weeks
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