Clinical trial: A Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia (NCT04554953)

Eligibility criteria:
Inclusion Criteria:

        Participation in this study is possible only if all of the inclusion criteria below are
        satisfied.

          1. 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

          2. Adult males and females aged 19 years or above

          3. 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 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)

        Exclusion Criteria:

        Patients cannot participate in this study if any of the following exclusion criteria is
        applicable.

          1. Contraindication according to the drug labeling of the combination drug ingredients
             (fimasartan, amlodipine) for hypertension containing fimasartan

          2. Contraindication according to the drug labeling of statins (rosuvastatin,
             atorvastatin)

          3. Secondary hypertension or suspected secondary hypertension - Aortic coarctation,
             hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma,
             Cushing's syndrome, polycystic kidney disease, etc.

          4. Secondary dyslipidemia or suspected secondary dyslipidemia

             - Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome,
             etc.

          5. Patients currently hospitalized or scheduled to be hospitalized

          6. 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

          7. Patients who are deemed ineligible for study participation at the discretion of the
             investigators for other reasons

             -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Entailment