An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks

NCT ID: NCT00695305

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-05-31

Brief Summary

A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.

Detailed Description

Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity, plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.

Conditions

Atherosclerosis

Keywords

rilapladib,; Lp-PLA2,; atherosclerosis; SB-659032,; FDG-PET,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

placebo to match

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

rilapladib

250 mg/day

Group Type: ACTIVE_COMPARATOR

rilapladib

Intervention Type: DRUG

250 mg oral dose once daily

18F Fluorodeoxylucose (FDG)-PET

Intervention Type: OTHER

FDG-PET

Interventions

rilapladib

250 mg oral dose once daily

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

18F Fluorodeoxylucose (FDG)-PET

FDG-PET

Intervention Type: OTHER

Other Intervention Names

SB-659032; FDG marker

Eligibility Criteria

Inclusion Criteria

• Capable of giving written informed consent and able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
• Male or female, aged 50 to 80 years inclusive, at screening.
• Females must be of non-childbearing potential
• Body weight ≥ 50 kg and BMI within the range 19-35 kg/m2
• Documented atherosclerotic vascular disease (e.g. prior MI, prior revascularization, peripheral arterial disease, carotid disease, or cerebrovascular disease) and clinically stable for at least 6 months
• If diabetic, have well controlled diabetes, defined for the purpose of this study as HbA1c ≤8% or FPG ≤200 mg/dL
• Evidence of plaque inflammation [carotid artery or ascending aorta plaque inflammation defined as a tissue to background ratio (TBR) ≥ 1.6]
• On a stable dose of a statin for 3 months prior to screening with no evidence of statin intolerance

Exclusion Criteria

• Recent (i.e., <6 months from Screening Visit) CV event defined as ST-elevation MI or non-ST-elevation MI, confirmed by cardiac enzyme elevation and ECG changes, coronary revascularization (PCI or CABG), stroke of any etiology, resuscitated sudden death, prior carotid surgery or stenting procedure
• Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.
• Exposure to substantial radiation within the past 12 months
• Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy), PCI or major non-cardiac surgery within the study period
• Current inadequately controlled hypertension (blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic) on a stable dose of anti-hypertensive medication
• Diabetics taking injectable insulin at screening
• Serum triglycerides >400 mg/dL, LDLc >130 mg/dL
• Recent (<1 month) or ongoing acute infection.
• History of chronic inflammatory disease
• Recently received (<1 month) or currently receiving oral or injectable corticosteroids, or regular use of nasal, inhaled or topical corticosteroids.
• Subjects who will commence, or who are likely to commence regular treatment with oral, non-steroidal anti-inflammatory drugs (NSAIDs) from screening until study completion
• Currently receiving oral or injectable potent CYP3A4 inhibitor(s)
• History of chronic viral hepatitis or other chronic hepatic disorders; or ALT or AST >1.5 x ULN, or alkaline phosphatase or total bilirubin >1.5 x ULN of laboratory reference range at Screen
• Renal impairment with serum creatinine >2.0 mg/dl or history of kidney transplant or status post nephrectomy.
• History of myopathy or inflammatory muscle disease, or elevated total CPK at screening
• History of severe heart failure defined as NYHA class III or IV or those with known severe left ventricular dysfunction (ejection fraction<30%) regardless of symptomatic status
• History of adult asthma (or reactive airway disease) manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)
• History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions or severe allergic responses
• History of malignancy within the past 2 years.
• A history of glaucoma or any other findings in the baseline eye exam
• Current life-threatening condition other than vascular disease that may prevent a subject from completing the study
• QTc interval ≥450msec at screening or ≥480 msec for subjects with bundle branch block
• History of drug abuse within the past 6 months
• Previous exposure to rilapladib.
• Contraindication to MRI scanning
• Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
• Any other subject the Investigator deems unsuitable for the study

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Brockton, Massachusetts, United States

GSK Investigational Site

Haverhill, Massachusetts, United States

GSK Investigational Site

Linden, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

North Massapequa, New York, United States

GSK Investigational Site

Warwick, Rhode Island, United States

Countries

United States

Study Documents

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

LP2105521

Identifier Type: -

Identifier Source: org_study_id