Study In Patients With Dyslipidaemia

NCT ID: NCT00264667

Last Updated: 2016-10-28

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

PHASE2

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-06-30

Brief Summary

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Study in patients with dyslipidaemia.

Detailed Description

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Conditions

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Metabolic Syndrome X

Keywords

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Dyslipidaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW677954

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Waist circumference =102cm (men) or =88cm (women) at visit 1.
* Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1.
* Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1.
* Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.

Exclusion Criteria

* History of diabetes
* History of cardiovascular disease
* Diagnosis of genetic lipid disorders
* History of muscle pain
* History of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

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Córdoba, , Argentina

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San Juan, , Argentina

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Kippa-Ring, Queensland, Australia

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Meadowbrook, Queensland, Australia

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Elizabeth Vale, South Australia, Australia

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Keswick, South Australia, Australia

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Camperdown, Victoria, Australia

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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San José, , Costa Rica

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Ahmedabad, , India

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Bangalore, , India

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Bangalore, , India

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Chennai, , India

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Mumbai, , India

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Durango, Durango, Mexico

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Pachuca, Hidalgo, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, , Mexico

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Rotorua, , New Zealand

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Karachi, , Pakistan

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Lahore, , Pakistan

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Brasov, , Romania

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Bucharest, , Romania

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Deva, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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S.-Petresburg, , Russia

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Košice, , Slovakia

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Košice, , Slovakia

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Granada, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Móstoles/Madrid, , Spain

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GSK Investigational Site

Santiago de Compostela, , Spain

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GSK Investigational Site

Tarrasa, Barcelona, , Spain

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Countries

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Croatia Argentina Australia Chile Costa Rica India Latvia Mexico New Zealand Pakistan Romania Russia Slovakia Spain

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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ADG103440

Identifier Type: -

Identifier Source: org_study_id