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

Official Title: “Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.”

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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)

Primary Measures

• Left ventricular mass reduction.
  • Time Frame: 6 Month(s)
    Safety Issue?: No

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
• C-LDL > 190 mg/Dl
• History Of Myocardial Infarction Or Stable Chronic Angina
• Triglycerides >250 mg/Dl

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00738972

Study ID Number: MK-0653A-168

ClinicalTrials.gov Identifier: NCT00738972

Health Authority: Mexico: Ministry of Health