Effects of Atorvastatin on Blood Pressure and Urinary Alb... | NCT01126684

Studies
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

NCT01126684

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

May 20, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hypertension
Hypercholesterolemia

Interventions

Atorvastatin
Placebo

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Not provided

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

May 19, 2010

First Posted Date

May 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2010

Last Update Posted Date

May 20, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin	Active Comparator		Drug: Atorvastatin
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	10 mg of atorvastatin once daily for six months	Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ambulatory blood pressure		Six months

Secondary Outcomes

Measure	Description	Time Frame
Urinary Albumin Excretion		Six months
Insulin Sensitivity		Six months
Arterial Stiffness

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anastasios Lasaridis, MD, PhD	Aristotle University Of Thessaloniki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AHEPA University Hospital of Thessaloniki		Thessaloniki		54636	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23449607	Derived	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.

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia
D000075222	Essential Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds