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

This study has been terminated.
(Study terminated early due to sample size, not possible to perform further statistical analysis.)
Sponsor:
Information provided by (Responsible Party):
Fundación Lindavista del Corazón AC
ClinicalTrials.gov Identifier:
NCT00738972
First received: August 19, 2008
Last updated: August 17, 2013
Last verified: August 2013
  Purpose

Evaluate pleiotropic effects of simvastatin in hypertensive patients.


Condition Intervention Phase
Hypertension
Drug: valsartan
Drug: pravastatin
Drug: simvastatin
Drug: ezetimibe (+) simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.

Resource links provided by NLM:


Further study details as provided by Fundación Lindavista del Corazón AC:

Primary Outcome Measures:
  • Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients [ Time Frame: 6 Month(s) ] [ Designated as safety issue: No ]
    Left ventricular hypertrophy reduction was to be measured by echocardiography.


Enrollment: 12
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • valsartan
  • Diovan
Drug: pravastatin
40 mg pravastatin. Duration: 12 months. Tablets
Other Names:
  • pravastatin
  • 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:
  • valsartan
  • Diovan
Drug: simvastatin
40 mg simvastatin. Duration: 12 months. Tablets
Other Names:
  • simvastatin
  • 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:
  • valsartan
  • 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 Names:
  • valsartan
  • Diovan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738972

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

No publications provided

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
Study First Received: August 19, 2008
Results First Received: July 20, 2013
Last Updated: August 17, 2013
Health Authority: Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014