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)

Coronary Heart Disease Clinical Trial

Official title:

SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636271
• Other study ID #: 116740
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: October 30, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28855
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• darapladib
darapladib enteric coated tablets 160 mg
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to first occurrence of urgent coronary revascularization for myocardial ischemia	time to the first occurrence of any urgent coronary revascularization for myocardial ischemia	visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.	No
Primary	The time to first occurrence of stroke (fatal/non-fatal)	time to the first occurrence of stroke (fatal or non-fatal)	visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.	No
Primary	The time to subsequent Major Adverse Cardiovascular Events (MACE)	time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)	visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.	No
Primary	The time to first occurrence of heart failure requiring hospitalization	time to the first occurrence of heart failure requiring hospitalization	visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.	No