Pleiotropism of Statin Therapy in High Dose Versus Low Do... | NCT01241097

Studies
Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

NCT01241097

Sponsor

Federal University of Bahia

Status

Unknown status

Last Update Posted

Nov 16, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Endothelial Function

Interventions

simvastatin, combined with simvastatin ezetimibe, placebo

Countries

Brazil

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

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 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

Nov 15, 2010

Last Update Posted Date

Nov 16, 2010Estimated

Name	Class
Escola Bahiana de Medicina e Saude Publica	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test the hypothesis that therapy with high dose statin provides endothelial superior benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.
To test the hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose of statin plus ezetimibe

Detailed Description

Randomized, double-blind, placebo-controlled study. Inclusion Criteria: Obese women with body mass index (BMI)> 25 kg / m², aged 18 years and LDL-C> 100 mg / dl For treatment with simvastatin 80 mg, the participant will receive two identical vials, each containing a simvastatin 40 mg. For treatment with the combination simvastatin 10 mg and ezetimibe 10 mg, the participant will receive two identical bottles, one bottle with simvastatin 10 mg, and another bottle with ezetimibe 10mg. In the control group, each participant will receive two identical bottles, each bottle containing inert tablets. Each group with 20 participants.

Dependent Variable (Final Primary Outcome): Percentage change vasodilation of brachial artery flow-mediated, after treatment for eight weeks.

Covariates: clinical, biochemical markers and ultrasound.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-dose simvastatin, combined, placebo	Experimental	simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo	Drug: simvastatin, combined with simvastatin ezetimibe, placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
simvastatin, combined with simvastatin ezetimibe, placebo	Drug	simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo

Measure	Description	Time Frame
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.		8 weeks

Measure	Description	Time Frame
biochemical markers		8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with body mass index (BMI)> 25 kg / m²
Aged > 18 years
LDL-C> 100 mg / dl

Exclusion Criteria:

Previous use of statins, fibrates or ezetimibe
Triglycerides> 400 mg / dl
Serum creatinine greater than 2.0 md / dl
Elevated liver enzymes, more than one and half times the upper limit of normal
Creatine kinase (CK) levels more than three times the upper limit of normal
Pregnant
Breast-feeding
Heart failure
Psychiatric disorders
Hormone replacement therapy.
The occurrence of recent onset within the last four weeks of treatment with beta-blockers, converting enzyme inhibitor or calcium channel blocker, the intervention should be undertaken after a period of at least four weeks of continuous use.
Acute inflammatory processes in the last month, assessed by clinical history and physical examination (ear, throat, skin lesions or other inflammatory manifestations) as well as reports of chronic diseases such as collagen, or the occurrence of active tuberculosis in the last three months will be excluded from work.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maristela M Garcia, MD	Contact	55-71-99739981		marismacardiol@gmail.com
Luis Claudio L Correia, Phd	Contact	55-71-99711032		lccorreia@terra.com.br

Overall Officials

Name	Affiliation	Role
Maristela M Garcia, MD	Escola Bahiana de Medicina e Saúde Pública	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Escola Bahiana de Medicina e Saúde Púiblica	Recruiting	Salvador	Estado de Bahia	40000	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D019821	Simvastatin
D000069499	Ezetimibe, Simvastatin Drug Combination

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

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Browse Branches

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