A Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia

NCT04554953 | Completed

• 1 other identifier: BR-FMS-OS-406
• Study Type: observational
• Target: 10,877
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the effectiveness of a combination drug containing fimasartan and statins on the control of hypertension and dyslipidemia, and the secondary objective is to evaluate the drug cost reduction effect, patients' satisfaction level and safety of the combination drug administration.

Conditions

Hypertension and Dyslipidemia

Keywords

Fimasartan and Statins

Outcome Measures

Primary Outcomes (2)

• Blood pressure controlled to the target level

  Proportion of patients with blood pressure controlled to the target level (SiSBP, SiDBP) according to '2018 Guidelines for Management of Hypertension2' at Week 12. Site staff will be measuring Systolic and Diastolic Blood Pressure.

  Week12

• LDL-C controlled to the target level

  Proportion of patients with LDL-C controlled to the target level according to 'Guidelines for Management of Dyslipidemia 4th Edition1' at Week 12

  Week 12

Secondary Outcomes (6)

• Medication Satisfaction Questionnaire

  Week 12

• Average cost-effectiveness ratio (ACER)

  Week 12

• both blood pressure and LDL-C controlled

  Week 12

• non-HDL-C controlled

  Week 12

• Change in blood pressure

  Week 12

Interventions

Combination drug containing fimasartan and statins DRUG

Patients who correspond to one of the following: 1. Patients who are planning to be treated with a combination drug containing fimasartan and statins after being newly diagnosed with essential hypertension and primary hypercholesterolemia 2. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension or primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB or dyslipidemia treatment that is containing a statin 3. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10,990 subjects This study involves patients with hypertension and dyslipidemia, and its purpose is to investigate the control rate of hypertension and dyslipidemia, drug cost reduction effect, patients' satisfaction level, and rare adverse events of combination drugs containing fimasartan and statins.

You may qualify if:

• Patients who provide written consent on the consent form for use of personal information after listening to explanations regarding the purpose, method, etc. of this study
• Adult males and females aged 19 years or above
• Patients who correspond to one of the following:
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• Patients who are planning to be treated with a combination drug containing fimasartan and statins after being newly diagnosed with essential hypertension and primary hypercholesterolemia
• Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension or primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB or dyslipidemia treatment that is containing a statin
• Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin 4. The following test results available within 4 weeks prior to the enrollment date
• Total Cholesterol (TC)
• HDL-C ③ Triglyceride (TG) ④ LDL-C or LDL-C (Friedewald formula\*)
• non-HDL-C (Total cholesterol - HDL-C (mg/dL)) \*LDL-C = Total cholesterol - HDL-C - (triglyceride/5) (mg/dL)

You may not qualify if:

• Contraindication according to the drug labeling of the combination drug ingredients (fimasartan, amlodipine) for hypertension containing fimasartan
• Contraindication according to the drug labeling of statins (rosuvastatin, atorvastatin)
• Secondary hypertension or suspected secondary hypertension - Aortic coarctation, hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome, polycystic kidney disease, etc.
• Secondary dyslipidemia or suspected secondary dyslipidemia
• \- Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, etc.
• Patients currently hospitalized or scheduled to be hospitalized
• If an investigational drug has been administered within 12 weeks of the enrollment date, or if participation in another clinical study during this study participation period is planned
• Patients who are deemed ineligible for study participation at the discretion of the investigators for other reasons

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, 42, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: April 13, 2020
• Primary Completion: November 3, 2021
• Study Completion: May 31, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)