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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01636271
First received: May 31, 2012
Last updated: September 5, 2013
Last verified: August 2013

May 31, 2012
September 5, 2013
October 2011
May 2014   (final data collection date for primary outcome measure)
  • The time to first occurrence of urgent coronary revascularization for myocardial ischemia [ Time Frame: 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of any urgent coronary revascularization for myocardial ischemia
  • The time to first occurrence of stroke (fatal/non-fatal) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of stroke (fatal or non-fatal)
  • The time to subsequent Major Adverse Cardiovascular Events (MACE) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)
  • The time to first occurrence of heart failure requiring hospitalization [ Time Frame: 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of heart failure requiring hospitalization
Same as current
Complete list of historical versions of study NCT01636271 on ClinicalTrials.gov Archive Site
Not Provided
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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)
SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) or post Acute Coronary Syndrome (ACS)) randomized into the STABILITY trial (LPL100601) or the SOLID-TIMI 52 trial (SB-480848/033).

Coronary Heart Disease
  • Drug: darapladib
    darapladib enteric coated tablets 160 mg
  • Drug: placebo
    placebo
  • Group 1: subjects from LPL100601
    randomized subjects in study LPL100601
    Interventions:
    • Drug: darapladib
    • Drug: placebo
  • Group 2: subjects from SB480848/033
    randomized subjects in study SB480848/033
    Interventions:
    • Drug: darapladib
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28855
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01636271
116740
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP