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Study In Patients With Dyslipidaemia
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264667
  Purpose

Study in patients with dyslipidaemia.


Condition Intervention Phase
Dyslipidaemia
 Drug: GW677954
 Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 290
Study Start Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264667

  Show 51 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MA GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: ADG103440
Study First Received: December 9, 2005
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00264667  
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:
Dyslipidaemia

Study placed in the following topic categories:
Metabolic Diseases
Overweight
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009



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