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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00738972
Other study ID # MK-0653A-168
Secondary ID 2008_020
Status Terminated
Phase Phase 3
First received August 19, 2008
Last updated August 17, 2013
Start date January 2008
Est. completion date August 2010

Study information

Verified date August 2013
Source Fundación Lindavista del Corazón AC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate pleiotropic effects of simvastatin in hypertensive patients.


Other known NCT identifiers
  • NCT00621127

Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
valsartan
80 mg valsartan. Duration: 12 months. Tablets
pravastatin
40 mg pravastatin. Duration: 12 months. Tablets
simvastatin
40 mg simvastatin. Duration: 12 months. Tablets
ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundación Lindavista del Corazón AC

Outcome

Type Measure Description Time frame Safety issue
Primary Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients Left ventricular hypertrophy reduction was to be measured by echocardiography. 6 Month(s)
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