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

F

Fundación Lindavista del Corazón AC

Status and phase

Terminated
Phase 3

Conditions

Hypertension

Treatments

Drug: valsartan
Drug: pravastatin
Drug: ezetimibe (+) simvastatin
Drug: simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00738972
MK-0653A-168
2008_020

Details and patient eligibility

About

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 4 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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