Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00269048




Registration number
NCT00269048
Ethics application status
Date submitted
21/12/2005
Date registered
23/12/2005
Date last updated
8/08/2016

Titles & IDs
Public title
SB-480848 In Subjects With Coronary Heart Disease
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks
Secondary ID [1] 0 0
LPL104884
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB-480848
Treatment: Drugs - placebo

Experimental: Arm 1 - SB-480848

Placebo comparator: Arm 2 - placebo


Treatment: Drugs: SB-480848
SB-480848

Treatment: Drugs: placebo
placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
On treatment sustained inhibition of plasma Lp-PLA2 activity.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Difference in dose-dependent effects of SB-480848 on plasma Lp-PLA2 activity, other biomarkers, and safety.
Timepoint [1] 0 0
12 Weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

* Female subjects must be of non-childbearing potential.
* Stable CHD or CHD-risk equivalent.
* Must have been on a stable dose of a statin for =4 weeks with LDL <130 mg/dL (3.4 mmol/L) or off statin therapy for =4 weeks with LDL <160 mg/dL (4.1 mmol/L).
* On a stable dose of at least one oral antiplatelet agent (e.g., aspirin, clopidogrel, or ticlopidine).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Recent cardiovascular event and / or vascular procedure.
* History of difficult to manage dyslipidemia.
* Planned cardiac surgery or PCI (percutaneous coronary intervention) or planned major non-cardiac surgery.
* Inadequately controlled hypertension.
* Poorly controlled diabetes mellitus.
* Serum triglycerides >400 mg/dL (4.52 mmol/L).
* Recent or ongoing acute infection.
* History of chronic inflammatory disease.
* Receiving topical, oral, inhaled or injectable corticosteroids.
* History of chronic viral hepatitis, or other chronic hepatic disorders.
* History of kidney transplant.
* History of myopathy or inflammatory muscle disease, or elevated total serum CK (3 x ULN).
* Severe heart failure (NYHA class III or IV), or severe left ventricular dysfunction (ejection fraction <30%).
* Asthma manifested by bronchospasm in the past 6 months, or currently taking inhaled bronchodilator on regular basis.
* History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
* Malignancy within the past 2 years, other than non-melanoma skin cancer.
* Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
* QTc interval >440 msec (males) or >450 msec (females).
* Alcohol or drug abuse within the past 6 months.
* Previous exposure to SB-480848.
* Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication (blinded atorvastatin).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
969
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [2] 0 0
GSK Investigational Site - Caulfield
Recruitment hospital [3] 0 0
GSK Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
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Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
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United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autónoma de Buenos Aires
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Pleven
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Denmark
State/province [23] 0 0
Koebenhavn N
Country [24] 0 0
Estonia
State/province [24] 0 0
Tallinn
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Estonia
State/province [25] 0 0
Tartu
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France
State/province [26] 0 0
Anzin
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France
State/province [27] 0 0
Bron Cedex
Country [28] 0 0
France
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Créteil
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France
State/province [29] 0 0
Dommartin-les-Toul
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France
State/province [30] 0 0
Gières
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France
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Montbrison
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France
State/province [32] 0 0
Montpellier Cedex 5
Country [33] 0 0
France
State/province [33] 0 0
Pessac cedex
Country [34] 0 0
France
State/province [34] 0 0
Toulouse
Country [35] 0 0
Germany
State/province [35] 0 0
Baden-Wuerttemberg
Country [36] 0 0
Germany
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Bayern
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Germany
State/province [37] 0 0
Mecklenburg-Vorpommern
Country [38] 0 0
Germany
State/province [38] 0 0
Nordrhein-Westfalen
Country [39] 0 0
Germany
State/province [39] 0 0
Rheinland-Pfalz
Country [40] 0 0
Germany
State/province [40] 0 0
Sachsen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Debrecen
Country [45] 0 0
Hungary
State/province [45] 0 0
Szeged
Country [46] 0 0
Hungary
State/province [46] 0 0
Szolnok
Country [47] 0 0
India
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Banglore
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India
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Hyderabad
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India
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New Delhi
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Netherlands
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Den Helder
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Netherlands
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EDE
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Netherlands
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Enschede
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Netherlands
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Haarlem
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Netherlands
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Hoofddorp
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Netherlands
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Rotterdam
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Netherlands
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Sneek
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Netherlands
State/province [57] 0 0
Zeist
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New Zealand
State/province [58] 0 0
Hamilton
Country [59] 0 0
New Zealand
State/province [59] 0 0
Takapuna
Country [60] 0 0
Pakistan
State/province [60] 0 0
Karachi
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Romania
State/province [61] 0 0
Bucharest
Country [62] 0 0
Romania
State/province [62] 0 0
Bucuresti
Country [63] 0 0
Romania
State/province [63] 0 0
Targu-Mures
Country [64] 0 0
Spain
State/province [64] 0 0
Alicante
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
Cáceres
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Móstoles/Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Oviedo
Country [70] 0 0
Spain
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Palma de Mallorca
Country [71] 0 0
Spain
State/province [71] 0 0
Quart de Poblet, Valencia
Country [72] 0 0
Spain
State/province [72] 0 0
San Juan De Alicante
Country [73] 0 0
Spain
State/province [73] 0 0
Santiago de Compostela/La Coruña
Country [74] 0 0
Spain
State/province [74] 0 0
Santiago de Compostela
Country [75] 0 0
Spain
State/province [75] 0 0
Sta. Coloma de Gramanet/Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
Tarrasa, Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00269048