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

August 17, 2013 updated by: Fundación Lindavista del Corazón AC

Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: valsartan
80 mg valsartan. Duration: 12 months. Tablets
Other Names:
  • Diovan
Drug: pravastatin
40 mg pravastatin. Duration: 12 months. Tablets
Other Names:
  • Pravacol
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)
Drug: valsartan
80 mg valsartan. Duration: 12 months. Tablets
Other Names:
  • Diovan
Drug: simvastatin
40 mg simvastatin. Duration: 12 months. Tablets
Other Names:
  • Zocor
  • MK0733
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)
Drug: valsartan
80 mg valsartan. Duration: 12 months. Tablets
Other Names:
  • Diovan
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
Other Names:
  • MK0653A
  • vytorin
ACTIVE_COMPARATOR: Valsartan 80 mg
Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Drug: valsartan
80 mg valsartan. Duration: 12 months. Tablets
Other Names:
  • Diovan

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Lindavista del Corazón AC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 17, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-0653A-168
  • 2008_020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on valsartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe