Clinical trial: Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia. (NCT02662894)

Eligibility criteria:
Inclusion Criteria:

          -  Participants of both sexes aged between 18 and 65 years;

          -  Participants diagnosed with uncontrolled hypertension;

          -  Participants with intermediate and high risk dyslipidemia, according to the V
             Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;

          -  Ability to understand and consent to participate in this clinical study, manifested by
             signing the Informed Consent and Informed ( IC) .

        Exclusion Criteria:

          -  Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);

          -  Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin
             converting enzyme (ACE);

          -  participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V
             Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;

          -  research participants with total cholesterol (TC) above 500 mg / dL or triglyceride
             (TG) above 400 mg / dL;

          -  participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;

          -  research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg
             in orthostatic position in relation to the sitting position);

          -  History of congestive heart failure (CHF) functional class III or IV (NYHA);;

          -  any clinical, laboratory and electrocardiographic that, in the judgment of the
             investigator, may interfere with the safety of research participants;

          -  Creatine phosphokinase (CPK) levels above the established laboratory normal range;

          -  Transaminases (ALT and ASL) serum above 2 times the established laboratory normal
             range;

          -  Body mass index (BMI) ≥35 kg / m²;

          -  Immunocompromised participants (eg .: malignancies, patients with Acquired
             Immunodeficiency Syndrome etc);

          -  Chronic use of drugs that may interact with the drugs of the study;

          -  Patients on concomitant lipid-lowering therapy;

          -  History hypersensitivity to the active ingredients used in the study;

          -  Participants who are pregnant, nursing or planning to become pregnant, or female
             participants of childbearing potential who are not using a reliable method of
             contraception;

          -  History of alcohol abuse or illicit drug use;

          -  Adherence to uniformization medication <80%;

          -  Participating in the research that has participated in clinical trial protocols in the
             last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J),
             unless the investigator considers that there may be direct benefit to it;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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? Contradiction