Clinical trial: Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia (NCT01402843)

Eligibility criteria:
Inclusion Criteria:

          1. Patients aged 20 and older

          2. Patients with Dyslipidemia

          3. Patients with hypertension

          4. Patients who voluntarily signed the consent form.

        Exclusion Criteria:

          1. Blood Pressure

               -  In case there is a sitting systolic blood pressure difference of 20mmHg and over
                  or sitting diastolic blood pressure is 10mmHg and over in selected arm.

               -  Patients with symptomatic orthostatic hypotension.

               -  Patients having the history of Secondary hypertension or suspected to be
                  Secondary hypertension, e.g., aortic coarctation, hyperaldosteronism, renal
                  artery stenosis, Cushing's disease, pheochromocytoma, polycystic renal disease,
                  etc.

          2. Patients with severe heart diseases (NYHA class-III and IV), with ischemic heart
             diseases (angina pectoris and myocardial infarction) and with peripheral vascular
             diseases, and patients who underwent percutaneous transluminal coronary angioplasty
             (PTCA) or treatments for coronary artery bypass graft within 6 months.

          3. Patients with clinically significant ventricular tachycardia or atrial fibrillation or
             atrial flutter, and patients with arrhythmia judged to be clinically significant by
             investigators.

          4. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive CAD, aortic
             stenosis and hemodynamically significant aortostenosis or mitral stenosis.

          5. Patients with severe cerebrovascular diseases.

          6. Patients with severe or malignant retinosis.

          7. Patients with consumption diseases or autoimmune diseases or connective tissue
             diseases

          8. Patients with endocrine or metabolic diseases that are known to affect serum lipid or
             lipoprotein.

               -  Patients with uncontrollable diabetes

               -  Patients with uncontrollable thyroid dysfunction

          9. Patients who underwent treatments that may affect lipid before the clinical trial.

         10. Patients having the history of myopathy or rhabdomyolysis.

         11. Patients with severe renal disorders or hepatic disorders.

         12. Patients with gastrointestinal diseases that may affect drug absorption, distribution,
             metabolism and excretion or who underwent such operations, or patients with present
             active gastritis or gastrointestinal hemorrhage or proctorrhagia or active and
             inflammatory bowel syndrome that has occurred within 12 months.

         13. All of patients with chronic inflammatory diseases whereto anti-inflammatory
             treatments need to be applied.

         14. Patients having the history of drug or alcohol abuse.

         15. Pregnant women and/or women in the lactation period or the child-bearing period.

         16. Patients who are hypersensitive to Pitavastatin and Valsartan.

         17. Patients who have taken other investigational drugs within 3 months before undergoing
             the screening test for this clinical trial.

         18. Patients judged to be unsuitable for this clinical trial by investigators.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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