Clinical trial: Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension (NCT03267329)

Eligibility criteria:
Inclusion Criteria (All of the followings)

          -  40 to 75 years old diagnosed with hypertension

          -  at screening, SBP ≥ 140 mmHg

          -  at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg

          -  at screening, ASCVD risk ≥ 5 %

          -  Those who did not take the dyslipidemic medications during screening or who stopped
             medication for more than 2 months

          -  at screening, 130 mg/dL ≤ Calculated (or Measured) Serum LDL-C ≤ 190 mg/dL

          -  Pregnancy test negative and and who has agreed to perform effective contraception
             during the clinical trial

        Exclusion Criteria (Any of the followings)

          -  known hypersensitivity to AT-1 receptor blockers or statins

          -  Those who are treated with secondary hypertension during screening

          -  Those who are being treated for malignant hypertension during screening

          -  Those who are taking concurrent medication that may affect blood pressure during
             screening

          -  Those who have been diagnosed with myocardial infarction or unstable angina or stroke
             within the last 6 months at screening

          -  Patients with heart failure NYHA III-IV or Left Ventricular Ejection Fraction <40%
             within the last 6 months at screening

          -  Patients with valve disease with hemodynamically significant (over moderate degree)
             obstructive

          -  Those with known atrial fibrillation or atrioventricular conduction disturbance

          -  Those who show the following numerical values during the screening test

               1. CPK ≥ 3 times the normal upper limit

               2. Serum Creatinine > 3 mg/dL

               3. Serum Potassium > 5.5 mmol/L

               4. ALT or AST ≥ 3 times the upper normal limit

          -  Those with known bilateral renal artery stenosis

          -  Patients who underwent open heart surgery within 4 weeks prior to randomization and
             who had a cardiac surgery plan

          -  Those taking statins within 8 weeks before randomization

          -  Those with severe obstructive, limited or other pulmonary disease history

          -  Those with non-cardiac disease that can significantly shorten the expected life span
             to less than 2 years (eg, severe cancer)

          -  at screening, Anti-HIV Ab, HBsAg, HCV Ab positive
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years

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? 1