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Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

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ClinicalTrials.gov Identifier: NCT01126684
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : May 20, 2010
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki

Brief Summary:
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.

Condition or disease Intervention/treatment Phase
Hypertension Hypercholesterolemia Drug: Atorvastatin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION
Study Start Date : June 2008
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin Drug: Atorvastatin
10 mg of atorvastatin once daily for six months

Placebo Comparator: Placebo Drug: Placebo
placebo once daily for six months




Primary Outcome Measures :
  1. Ambulatory blood pressure [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Urinary Albumin Excretion [ Time Frame: Six months ]
  2. Insulin Sensitivity [ Time Frame: Six months ]
  3. Arterial Stiffness [ Time Frame: Six months ]
  4. Urinary levels of nephrin [ Time Frame: Six months ]
  5. Urinary levels of podocalyxin [ Time Frame: Six months ]
  6. Urinary levels of Endothelin-1 [ Time Frame: Six months ]
  7. Urinary levels of Asymmetric Dimethylarginine [ Time Frame: Six months ]
  8. Urinary levels of indices of oxidative stress [ Time Frame: Six months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25).
  • no previous hypolipidemic medication
  • ability to provide Informed Consent.

Exclusion Criteria:

  • pregnancy or lactation
  • myocardial infarction or unstable angina within the past 6 months
  • heart failure NYHA class III-IV
  • renal disease (SCr>3 mg/dL or proteinuria>3g/d)
  • liver disease
  • history of malignancy
  • history of drug or alcohol abuse
  • treatment with corticosteroids
  • any other condition with poor prognosis
  • inability to provide Informed Consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126684


Locations
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Greece
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Anastasios Lasaridis, MD, PhD Aristotle University Of Thessaloniki
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lasaridis Anastasios, Professor of Internal Medicine and Nephrology, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01126684    
Other Study ID Numbers: STAY
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: April 2010
Keywords provided by Aristotle University Of Thessaloniki:
essential hypertension
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors