NCT01126684

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
Last Updated

May 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

May 19, 2010

Last Update Submit

May 19, 2010

Conditions

HypertensionHypercholesterolemia

Keywords

essential hypertension

Outcome Measures

Primary Outcomes (1)

  • Ambulatory blood pressure

    Six months

Secondary Outcomes (8)

  • Urinary Albumin Excretion

    Six months

  • Insulin Sensitivity

    Six months

  • Arterial Stiffness

    Six months

  • Urinary levels of nephrin

    Six months

  • Urinary levels of podocalyxin

    Six months

  • +3 more secondary outcomes

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR
Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AtorvastatinDRUG

10 mg of atorvastatin once daily for six months

Atorvastatin
PlaceboDRUG

placebo once daily for six months

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Related Publications (1)

  • 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.

    PMID: 23449607DERIVED

MeSH Terms

Conditions

HypertensionHypercholesterolemiaEssential Hypertension

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Anastasios Lasaridis, MD, PhD

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Last Updated

May 20, 2010

Record last verified: 2010-04

Locations

GR(1)