Hypertension
Conditions
Brief summary
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
Interventions
DRUGvalsartan
80 mg valsartan. Duration: 12 months. Tablets
DRUGpravastatin
40 mg pravastatin. Duration: 12 months. Tablets
DRUGsimvastatin
40 mg simvastatin. Duration: 12 months. Tablets
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
Sponsors
Fundación Lindavista del Corazón AC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients | 6 Month(s) | Left ventricular hypertrophy reduction was to be measured by echocardiography. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 3 |
| 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) | 3 |
| 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) | 3 |
| Valsartan 80 mg Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) | 2 |
| Total | 11 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Customized >18 years | 3 participants | 3 participants | 3 participants | 2 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Time frame: 6 Month(s)
Population: This study was terminated early and due to sample size it was not possible to perform further statistical analyses.