NCT00669435

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

Enrollment Period

Same day

First QC Date

April 25, 2008

Last Update Submit

April 28, 2008

Conditions

Hypertension

Keywords

Essential hypertensionLiver steatosis

Outcome Measures

Primary Outcomes (1)

  • All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.

    Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

Secondary Outcomes (1)

  • Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR

    Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Amlodipine and Simvastatin

Drug: Amlodipine + Simvastatin

2

EXPERIMENTAL

Losartan and Simvastatin

Drug: Losartan + Simvastatin

Interventions

Losartan + SimvastatinDRUG

tablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months

2
Amlodipine + SimvastatinDRUG

tablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months

1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, Italy

RECRUITING

MeSH Terms

Conditions

HypertensionEssential HypertensionFatty Liver

Interventions

LosartanSimvastatinAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDihydropyridinesPyridines

Central Study Contacts

Giuseppe Derosa

CONTACT

39-038-250-2614

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 30, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations

IT(1)