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Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by University of Pavia.
Recruitment status was:  Recruiting
Information provided by:
University of Pavia Identifier:
First received: April 25, 2008
Last updated: April 28, 2008
Last verified: April 2008
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

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 ]

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 ]

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


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00669435

Contact: Giuseppe Derosa 39-038-250-2614

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

Responsible Party: Giuseppe Derosa/MD, University of Pavia Identifier: NCT00669435     History of Changes
Other Study ID Numbers: UNIPV003DIM2008
Study First Received: April 25, 2008
Last Updated: April 28, 2008

Keywords provided by University of Pavia:
Essential hypertension
Liver steatosis

Additional relevant MeSH terms:
Fatty Liver
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on August 18, 2017