Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia

Last updated: May 12, 2014
Sponsor: JW Pharmaceutical
Overall Status: Completed

Phase

3

Condition

Dyslipidemia

Stress

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT01402843
CWP-PTV-301
  • Ages > 20
  • All Genders

Study Summary

Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a representative ARB-series anti-hypertensive drug, have been authorized for use also in South Korea. They have been tested in many countries and proved to be effective and safe. The concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs and antihypertensive drugs are simultaneously administered to such patients. The combined administration of statin-series drugs and CCB-series drugs have.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Blood Pressure
  • In case there is a sitting systolic blood pressure difference of 20mmHg and overor 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 beSecondary hypertension, e.g., aortic coarctation, hyperaldosteronism, renalartery stenosis, Cushing's disease, pheochromocytoma, polycystic renal disease,etc.

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

  2. Patients with clinically significant ventricular tachycardia or atrial fibrillation oratrial flutter, and patients with arrhythmia judged to be clinically significant byinvestigators.

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

  4. Patients with severe cerebrovascular diseases.

  5. Patients with severe or malignant retinosis.

  6. Patients with consumption diseases or autoimmune diseases or connective tissuediseases

  7. Patients with endocrine or metabolic diseases that are known to affect serum lipid orlipoprotein.

  • Patients with uncontrollable diabetes

  • Patients with uncontrollable thyroid dysfunction

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

  2. Patients having the history of myopathy or rhabdomyolysis.

  3. Patients with severe renal disorders or hepatic disorders.

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

  5. All of patients with chronic inflammatory diseases whereto anti-inflammatorytreatments need to be applied.

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

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

  8. Patients who are hypersensitive to Pitavastatin and Valsartan.

  9. Patients who have taken other investigational drugs within 3 months before undergoingthe screening test for this clinical trial.

  10. Patients judged to be unsuitable for this clinical trial by investigators.

Study Design

Total Participants: 150
Study Start date:
June 01, 2011
Estimated Completion Date:
January 31, 2013

Study Description

This clinical trial was conducted to evaluate the safety and effectiveness of the combined administration of Pitavastatin and Valsartan to ethnic Koreans with dyslipidemia concurrent with hypertension, as well as to research the influence on the pharmacodynamic interaction between the two drugs.

Connect with a study center

  • Chungbuk National University Hospital

    Chung Ju,
    Korea, Republic of

    Site Not Available

  • Konyang University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hallym University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Medical Center

    Suwon,
    Korea, Republic of

    Site Not Available

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