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Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Pavia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pavia
ClinicalTrials.gov Identifier:
NCT00669435
First received: April 25, 2008
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Losartan + Simvastatin
Drug: Amlodipine + Simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pavia:

Primary Outcome Measures:
  • 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. [ Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR [ Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Amlodipine and Simvastatin
 Drug: Amlodipine + Simvastatin

tablets; 5, 10 mg; od; 12 months

tablets; 20 mg; od; 6 months
Experimental: 2
Losartan and Simvastatin
 Drug: Losartan + Simvastatin

tablets; 50, 100 mg; od; 12 months

tablets; 20 mg; od; 6 months

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669435

Contacts
Contact: Giuseppe Derosa 39-038-250-2614

Locations
Italy
University of Pavia Recruiting
Pavia, Italy
Contact: Giuseppe Derosa, MD     39-038-250-2614        
Sponsors and Collaborators
University of Pavia
  More Information

No publications provided

Responsible Party: Giuseppe Derosa/MD, University of Pavia
ClinicalTrials.gov Identifier: NCT00669435     History of Changes
Other Study ID Numbers: UNIPV003DIM2008
Study First Received: April 25, 2008
Last Updated: April 28, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Pavia:
Essential hypertension
Liver steatosis

Additional relevant MeSH terms:
Fatty Liver
Hypertension
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Simvastatin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013