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Status:

COMPLETED

SB-480848 In Subjects With Coronary Heart Disease

Lead Sponsor:

GlaxoSmithKline

Conditions:

Atherosclerosis

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, ...

Detailed Description

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 stab...

Eligibility Criteria

Inclusion

  • 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).
  • 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).

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2006

    Estimated Enrollment :

    969 Patients enrolled

    Trial Details

    Trial ID

    NCT00269048

    Start Date

    November 1 2005

    End Date

    September 1 2006

    Last Update

    August 8 2016

    Active Locations (119)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 30 (119 locations)

    1

    GSK Investigational Site

    Birmingham, Alabama, United States, 35294

    2

    GSK Investigational Site

    Northport, Alabama, United States, 35476

    3

    GSK Investigational Site

    Phoenix, Arizona, United States, 85014

    4

    GSK Investigational Site

    Tucson, Arizona, United States, 85715