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

Study Overview
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Brief Summary
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Evaluate pleiotropic effects of simvastatin in hypertensive patients.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: valsartan
* Drug: pravastatin
* Drug: simvastatin
* Drug: ezetimibe (+) simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valsartan 80 mg + Paravastin 40 mg<br>Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) | Drug: valsartan<br>* 80 mg valsartan. Duration: 12 months. Tablets<br>* Other names: Diovan;Drug: pravastatin<br>* 40 mg pravastatin. Duration: 12 months. Tablets<br>* Other names: Pravacol;|
| Active Comparator: Valsartan 80 mg + Simvastatin 40 mg<br>Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) | Drug: valsartan<br>* 80 mg valsartan. Duration: 12 months. Tablets<br>* Other names: Diovan;Drug: simvastatin<br>* 40 mg simvastatin. Duration: 12 months. Tablets<br>* Other names: MK0733;|
| Experimental: Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg<br>Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) | Drug: valsartan<br>* 80 mg valsartan. Duration: 12 months. Tablets<br>* Other names: Diovan;Drug: ezetimibe (+) simvastatin<br>* ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets<br>* Other names: MK0653A;|
| Active Comparator: Valsartan 80 mg<br>Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) | Drug: valsartan<br>* 80 mg valsartan. Duration: 12 months. Tablets<br>* Other names: Diovan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients | Left ventricular hypertrophy reduction was to be measured by echocardiography. | 6 Month(s) |