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SILVHIA: Irbesartan vs Atenolol in Hypertension with LVH
NCT00389168Phase 3
Key facts
- Status
- Completed
- Start
- Apr 1995
- Primary completion
- Apr 1997
- Countries
- 1
- Sponsor
- Karolinska Institutet
- Modality
- Small Molecules
- Drugs
- irbesartan
- Conditions
- hypertension (HTN)left ventricular hypertrophy (LVH)
01
Overview
Phase 3, randomised, double-blind trial of irbesartan in hypertension (HTN) and left ventricular hypertrophy (LVH) (2 arms), sponsored by Karolinska Institutet. Primary endpoint: Changes in Left Ventricular Mass Index at 48 weeks. Started Apr 1995; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Irbesartan
Irbesartan titrated to 300 mg od
Atenolol
Atenolol titrated to 100 mg od
03
Who it enrols
Adult patients with hypertension (DBP 90-115 mmHg) and echocardiographically established left ventricular hypertrophy. Excludes patients with coronary artery disease, heart failure, recent stroke, or uncontrolled diabetes.
04
Endpoints
Primary
Changes in Left Ventricular Mass Index
Secondary
Number of Participants With Serious Adverse Events
Left Ventricular Diastolic Function Assessed by the E/A Ratio
Blood Pressure
Changes of Venous Plasma Angiotensin II
Effects on Carotid Artery Wall Thickness
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