SB-480848 in Major Adverse Cardiovascular Events - Integrated Summary of Efficacy and Safety From the STABILITY Trial (LPL100601) and the SOLID-TIMI-52 Trial (SB-480848/033)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: darapladib; Drug: placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT01636271

116740

Details and patient eligibility

About

The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively.

Full description

The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)).

The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent MACE, and heart failure requiring hospitalization, For all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.

Enrollment: 28,855 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• This is an integrated analysis therefore inclusion criteria are not applicable.

Exclusion criteria

• This is an integrated analysis therefore exclusion criteria are not applicable.

Trial design

28,855 participants in 2 patient groups

Group 1: subjects from LPL100601

Description:

randomized subjects in study LPL100601

Treatment:

Drug: darapladib

Drug: placebo

Group 2: subjects from SB480848/033

Description:

randomized subjects in study SB480848/033

Treatment:

Drug: darapladib

Drug: placebo