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

Phase 3

Terminated

• Conditions: Hypertension
• Interventions: Drug: valsartan; Drug: pravastatin; Drug: ezetimibe (+) simvastatin; Drug: simvastatin

• Registration Number: NCT00738972
• Lead Sponsor: Fundación Lindavista del Corazón AC

Brief Summary

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-21
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Disposition First Submitted: 2011-08-16
• Disposition First Submitted QC: 2011-08-16
• Disposition First Posted: 2011-08-23
• Results First Submitted: 2013-07-20
• Results First Submitted QC: 2013-07-20
• Status Verified: 2013-08
• Results First Posted: 2013-08-13
• Last Update Submitted: 2013-08-17
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan 80 mg + Paravastin 40 mg	valsartan	Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
Valsartan 80 mg + Paravastin 40 mg	pravastatin	Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg	ezetimibe (+) simvastatin	Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
Valsartan 80 mg + Simvastatin 40 mg	valsartan	Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
Valsartan 80 mg	valsartan	Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Valsartan 80 mg + Simvastatin 40 mg	simvastatin	Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg	valsartan	Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)

Primary Outcome Measures

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