Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

Overview

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Full Title of Study: “Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: valsartan
    • 80 mg valsartan. Duration: 12 months. Tablets
  • Drug: pravastatin
    • 40 mg pravastatin. Duration: 12 months. Tablets
  • Drug: simvastatin
    • 40 mg simvastatin. Duration: 12 months. Tablets
  • Drug: ezetimibe (+) simvastatin
    • ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Arms, Groups and Cohorts

  • Active Comparator: Valsartan 80 mg + Paravastin 40 mg
    • Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
  • Active Comparator: Valsartan 80 mg + Simvastatin 40 mg
    • Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
  • Experimental: Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
    • Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
  • Active Comparator: Valsartan 80 mg
    • Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)

Clinical Trial Outcome Measures

Primary Measures

  • Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
    • Time Frame: 6 Month(s)
    • Left ventricular hypertrophy reduction was to be measured by echocardiography.

Participating in This Clinical Trial

Inclusion Criteria

  • Females Or Males Over 18 Years Old – Patients With Systemic Arterial Hypertension Grade I And II According With The European Society Of Cardiology – Left Ventricular hypertrophy Demonstrated By Echocardiography – Mild To Moderated hypercholesterolemia – Willing To Participate And Sign The Informed Consent Form (ICF) Exclusion Criteria:

  • Type 1 Or 2 Diabetes Mellitus – Familiar hypercholesterolemia – Low Density Lipoprotein-Cholesterol (LDL-C) > 190 mg/dl – History Of Myocardial Infarction Or Stable Chronic Angina – Triglycerides >250 mg/dl

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Lindavista del Corazón AC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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