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Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

NCT ID: NCT00669435

Last Updated: 2008-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.

Detailed Description

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Conditions

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Hypertension

Keywords

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Essential hypertension Liver steatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Amlodipine and Simvastatin

Group Type ACTIVE_COMPARATOR

Amlodipine + Simvastatin

Intervention Type DRUG

tablets; 5, 10 mg; od; 12 months

tablets; 20 mg; od; 6 months

2

Losartan and Simvastatin

Group Type EXPERIMENTAL

Losartan + Simvastatin

Intervention Type DRUG

tablets; 50, 100 mg; od; 12 months

tablets; 20 mg; od; 6 months

Interventions

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Losartan + Simvastatin

tablets; 50, 100 mg; od; 12 months

tablets; 20 mg; od; 6 months

Intervention Type DRUG

Amlodipine + Simvastatin

tablets; 5, 10 mg; od; 12 months

tablets; 20 mg; od; 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gender: 50% Male and 50% female
* Age: 40-80 years
* Race: Caucasian
* Overweight or obese: respectively BMI25-30 kg/m2 or BMI \> 30 kg m2
* Hypertensive: PA \> 140/90 mmHg
* Normocholesterolemic (LDL\< 160 mg/dl HDL \> 35 mg/dl)
* Liver steatosis

Exclusion Criteria

* other antihypertensive treatment after wash out period of 2 weeks
* abnormal heart rest function (EF \< 55%).
* valvular heart disease
* congenital heart disease
* heart failure or prior myocardial infarction
* diabetes
* renal disease
* liver disease
* connective tissue disease
* pregnancy or lactation
* serious adverse experience
* sensitivity to the study drugs or its components
* contraindication from an approved label
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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University of Pavia

Locations

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University of Pavia

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Derosa

Role: CONTACT

Phone: 39-038-250-2614

Facility Contacts

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Giuseppe Derosa, MD

Role: primary

Other Identifiers

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UNIPV003DIM2008

Identifier Type: -

Identifier Source: org_study_id