MedDataX Logo

Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

NCT ID: NCT00411073

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

darapladib moxifloxacin QT study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Darapladib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy
* Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
* Signed and dated written informed consent prior to admission to the study
* Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion Criteria

* cardiac abnormalities
* history of asthma or severe allergic reactions
* history of alcohol or drug abuse
* use of prescription or non-prescription drugs or vitamins or herbal supplements
* history of cholecystectomy or biliary tract disease
* pregnant or nursing women
* history of allergy to the study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Evansville, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Related Links

Access external resources that provide additional context or updates about the study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

SB 480848/035

Identifier Type: -

Identifier Source: org_study_id