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OpenTrials
Completed

NCT Number: NCT01126684

Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Essential Hypertension Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHEPA University Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

10 mg of atorvastatin once daily for six months

Placebo

Drug

placebo once daily for six months

Primary outcomes

  1. Ambulatory blood pressure

    Time frame: Six months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION

Important dates

Study start
2008
Primary completion
2009
First posted
May 20, 2010
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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