Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

NCT ID: NCT01126684

Last Updated: 2010-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

10 mg of atorvastatin once daily for six months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo once daily for six months

Interventions

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Atorvastatin

10 mg of atorvastatin once daily for six months

Intervention Type DRUG

Placebo

placebo once daily for six months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Aristotle University of Thessaloniki

Principal Investigators

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Anastasios Lasaridis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

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AHEPA University Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.

Reference Type DERIVED
PMID: 23449607 (View on PubMed)

Other Identifiers

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STAY

Identifier Type: -

Identifier Source: org_study_id

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