Study In Patients With Dyslipidaemia

October 26, 2016 updated by: GlaxoSmithKline

A Randomised,Double-blind, Parallel Group, Placebo-controlled, Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of Oral GW677954 Capsules 2.5mg, 5mg, 10mg and 20mg a Day for 24 Weeks in Overweight Dyslipidaemic Subjects

Study in patients with dyslipidaemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

290

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Buenos Aires, Argentina
        • GSK Investigational Site
      • Cordoba, Argentina, 5016
        • GSK Investigational Site
      • San Juan, Argentina, 5400
        • GSK Investigational Site
    • Córdova
      • Cordoba, Córdova, Argentina, 5000
        • GSK Investigational Site
      • Córdoba, Córdova, Argentina, 5000
        • GSK Investigational Site
  • Australia
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Meadowbrook, Queensland, Australia, 4131
        • GSK Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • GSK Investigational Site
      • Keswick, South Australia, Australia, 5035
        • GSK Investigational Site
    • Victoria
      • Camperdown, Victoria, Australia, 2050
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7571831
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7510605
        • GSK Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • GSK Investigational Site
  • India
      • Ahmedabad, India, 380 052
        • GSK Investigational Site
      • Bangalore, India, 560 054
        • GSK Investigational Site
      • Bangalore, India, 560034
        • GSK Investigational Site
      • Chennai, India, 600 116
        • GSK Investigational Site
      • Mumbai, India, 400008
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV1038
        • GSK Investigational Site
      • Riga, Latvia, LV 1012
        • GSK Investigational Site
      • Riga, Latvia, LV1005
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 11650
        • GSK Investigational Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42039
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand, 1311
        • GSK Investigational Site
      • Christchurch, New Zealand, 8014
        • GSK Investigational Site
      • Rotorua, New Zealand, 3201
        • GSK Investigational Site
  • Pakistan
      • Karachi, Pakistan, 74800
        • GSK Investigational Site
      • Lahore, Pakistan, 54000
        • GSK Investigational Site
  • Romania
      • Brasov, Romania, 500366
        • GSK Investigational Site
      • Bucharest, Romania, 020045
        • GSK Investigational Site
      • Deva, Romania, 330084
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 111020
        • GSK Investigational Site
      • Moscow, Russian Federation, 121 552
        • GSK Investigational Site
      • Moscow, Russian Federation, 101990
        • GSK Investigational Site
      • S.-Petresburg, Russian Federation, 195067
        • GSK Investigational Site
  • Slovakia
      • Kosice, Slovakia, 041 90
        • GSK Investigational Site
      • Kosice, Slovakia, 040 22
        • GSK Investigational Site
  • Spain
      • Alicante, Spain, 03114
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Granada, Spain, 18003
        • GSK Investigational Site
      • Granada, Spain, 18014
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28037
        • GSK Investigational Site
      • Móstoles/Madrid, Spain, 28935
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Tarrasa, Barcelona, Spain, 08221
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.

Secondary Outcome Measures

Outcome Measure
Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADG103440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: ADG103440
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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