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

NCT ID: NCT00738972

Last Updated: 2013-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-08-31

Brief Summary

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Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

80 mg valsartan. Duration: 12 months. Tablets

pravastatin

Intervention Type DRUG

40 mg pravastatin. Duration: 12 months. Tablets

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)

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

80 mg valsartan. Duration: 12 months. Tablets

simvastatin

Intervention Type DRUG

40 mg simvastatin. Duration: 12 months. Tablets

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)

Group Type EXPERIMENTAL

valsartan

Intervention Type DRUG

80 mg valsartan. Duration: 12 months. Tablets

ezetimibe (+) simvastatin

Intervention Type DRUG

ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Valsartan 80 mg

Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

80 mg valsartan. Duration: 12 months. Tablets

Interventions

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valsartan

80 mg valsartan. Duration: 12 months. Tablets

Intervention Type DRUG

pravastatin

40 mg pravastatin. Duration: 12 months. Tablets

Intervention Type DRUG

simvastatin

40 mg simvastatin. Duration: 12 months. Tablets

Intervention Type DRUG

ezetimibe (+) simvastatin

ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Intervention Type DRUG

Other Intervention Names

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Diovan Pravacol Zocor MK0733 vytorin MK0653A

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Lindavista del Corazón AC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Mexico

Other Identifiers

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2008_020

Identifier Type: -

Identifier Source: secondary_id

MK-0653A-168

Identifier Type: -

Identifier Source: org_study_id

NCT00621127

Identifier Type: -

Identifier Source: nct_alias