Title

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

    Phase 3
  • Study Type

    Interventional
  • Study Participants

    12
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
Study Started
Jan 31
2008
Primary Completion
Aug 31
2010
Study Completion
Aug 31
2010
Results Posted
Aug 13
2013
Estimate
Last Update
Aug 26
2013
Estimate

Drug valsartan

80 mg valsartan. Duration: 12 months. Tablets

  • Other names: Diovan

Drug pravastatin

40 mg pravastatin. Duration: 12 months. Tablets

  • Other names: Pravacol

Drug simvastatin

40 mg simvastatin. Duration: 12 months. Tablets

  • Other names: Zocor, MK0733

Drug ezetimibe (+) simvastatin

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

  • Other names: vytorin, MK0653A

Valsartan 80 mg + Paravastin 40 mg Active Comparator

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 Active Comparator

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 Experimental

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 Active Comparator

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

Criteria

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

Summary

Valsartan 80 mg + Paravastin 40 mg

Valsartan 80 mg + Simvastatin 40 mg

Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg

Valsartan 80 mg

All Events

Event Type Organ System Event Term

Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients

Left ventricular hypertrophy reduction was to be measured by echocardiography.

Valsartan 80 mg + Paravastin 40 mg

Valsartan 80 mg + Simvastatin 40 mg

Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg

Valsartan 80 mg

Total

11
Participants

Age, Customized

Sex: Female, Male

Overall Study

Valsartan 80 mg + Paravastin 40 mg

Valsartan 80 mg + Simvastatin 40 mg

Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg

Valsartan 80 mg