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NCT01126684 Clinical Trial

Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01126684
Other study ID # STAY
Secondary ID
Status Completed
Phase N/A
First received May 19, 2010
Last updated May 19, 2010
Start date June 2008

Study information
Verified date April 2010
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority Greece:National Organization of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
10 mg of atorvastatin once daily for six months
• Placebo
placebo once daily for six months

Locations
Country Name City State
Greece AHEPA University Hospital of Thessaloniki Thessaloniki

Sponsors (1)
Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ambulatory blood pressure Six months No
Secondary Urinary Albumin Excretion Six months No
Secondary Insulin Sensitivity Six months No
Secondary Arterial Stiffness Six months No
Secondary Urinary levels of nephrin Six months No
Secondary Urinary levels of podocalyxin Six months No
Secondary Urinary levels of Endothelin-1 Six months No
Secondary Urinary levels of Asymmetric Dimethylarginine Six months No
Secondary Urinary levels of indices of oxidative stress Six months No
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