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

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ClinicalTrials.gov Identifier: NCT00738972
Recruitment Status : Terminated (Study terminated early due to sample size, not possible to perform further statistical analysis.)
First Posted : August 21, 2008
Results First Posted : August 13, 2013
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Fundación Lindavista del Corazón AC

Brief Summary:
Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Drug: pravastatin Drug: simvastatin Drug: ezetimibe (+) simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.
Study Start Date : January 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Diovan
Drug: pravastatin
40 mg pravastatin. Duration: 12 months. Tablets
Other Name: 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 Name: 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 Name: Diovan
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
Other Names:
  • vytorin
  • MK0653A
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 Name: Diovan



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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738972


Sponsors and Collaborators
Fundación Lindavista del Corazón AC
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Fundación Lindavista del Corazón AC
ClinicalTrials.gov Identifier: NCT00738972     History of Changes
Obsolete Identifiers: NCT00621127
Other Study ID Numbers: MK-0653A-168
2008_020
First Posted: August 21, 2008    Key Record Dates
Results First Posted: August 13, 2013
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Hypertrophy
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Simvastatin
Ezetimibe
Pravastatin
Valsartan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists