Back to resultsLeft Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
valsartan
pravastatin
simvastatin
ezetimibe (+) simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Active Comparator
Arm Label
Valsartan 80 mg + Paravastin 40 mg
Valsartan 80 mg + Simvastatin 40 mg
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
Valsartan 80 mg
Arm Description
Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Outcomes
Primary Outcome Measures
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Secondary Outcome Measures
Full Information
NCT ID
NCT00738972
First Posted
August 19, 2008
Last Updated
August 17, 2013
Sponsor
Fundación Lindavista del Corazón AC
1. Study Identification
Unique Protocol Identification Number
NCT00738972
Brief Title
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
Official Title
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to sample size, not possible to perform further statistical analysis.
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Lindavista del Corazón AC
4. Oversight
5. Study Description
Brief Summary
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan 80 mg + Paravastin 40 mg
Arm Type
Active Comparator
Arm Description
Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
Arm Title
Valsartan 80 mg + Simvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
Arm Title
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
Arm Type
Experimental
Arm Description
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
Arm Title
Valsartan 80 mg
Arm Type
Active Comparator
Arm Description
Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Intervention Type
Drug
Intervention Name(s)
valsartan
Other Intervention Name(s)
Diovan
Intervention Description
80 mg valsartan. Duration: 12 months. Tablets
Intervention Type
Drug
Intervention Name(s)
pravastatin
Other Intervention Name(s)
Pravacol
Intervention Description
40 mg pravastatin. Duration: 12 months. Tablets
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor, MK0733
Intervention Description
40 mg simvastatin. Duration: 12 months. Tablets
Intervention Type
Drug
Intervention Name(s)
ezetimibe (+) simvastatin
Other Intervention Name(s)
vytorin, MK0653A
Intervention Description
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
Primary Outcome Measure Information:
Title
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
Description
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Time Frame
6 Month(s)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
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