Study In Patients With Dyslipidaemia

Metabolic Syndrome X Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264667
• Other study ID #: ADG103440
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2005
• Last updated: October 26, 2016
• Start date: December 2005
• Est. completion date: June 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Study in patients with dyslipidaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Metabolic Syndrome X

Intervention

Drug:
• GW677954

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Cordoba
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Córdoba	Córdova
Argentina	GSK Investigational Site	San Juan
Australia	GSK Investigational Site	Camperdown	Victoria
Australia	GSK Investigational Site	Elizabeth Vale	South Australia
Australia	GSK Investigational Site	Keswick	South Australia
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Meadowbrook	Queensland
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Costa Rica	GSK Investigational Site	San Jose
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Mumbai
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Pachuca	Hidalgo
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Rotorua
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Lahore
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Deva
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	S.-Petresburg
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Kosice
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Tarrasa, Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Australia,  Chile,  Costa Rica,  India,  Latvia,  Mexico,  New Zealand,  Pakistan,  Romania,  Russian Federation,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Secondary	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.

External Links

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