To Evaluate Safety and Effectiveness of RovatitanTab.

May 18, 2020 updated by: LG Chem

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have hypertension and hyperlipidemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
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)
Drug: Rosuvastatin/Valsartan
Rovatitan QD for 12 weeks
Other Names:
  • Rovatitan Tab.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ratio of patients who reach the target BP and LDL-c
Time Frame: 12weeks
SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years), target LDL
12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Investigators

  • Principal Investigator: Kang seokmin, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VROS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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