To Evaluate Safety and Effectiveness of RovatitanTab.

NCT ID: NCT04398771

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-05-31

Brief Summary

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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

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

Conditions

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Hypertension Hyperlipidemias

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Rosuvastatin/Valsartan

Intervention Type DRUG

Rovatitan QD for 12 weeks

Interventions

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Rosuvastatin/Valsartan

Rovatitan QD for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Rovatitan Tab.

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kang seokmin

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Central Contacts

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songyi Park

Role: CONTACT

=82-2-6987-4195

Other Identifiers

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LG-VROS001

Identifier Type: -

Identifier Source: org_study_id

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