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)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Drug: darapladib Drug: placebo |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety |
- 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
| Enrollment: | 28855 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1: subjects from LPL100601
randomized subjects in study LPL100601
|
Drug: darapladib
darapladib enteric coated tablets 160 mg
Drug: placebo
placebo
|
|
Group 2: subjects from SB480848/033
randomized subjects in study SB480848/033
|
Drug: darapladib
darapladib enteric coated tablets 160 mg
Drug: placebo
placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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).
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01636271 History of Changes |
| Other Study ID Numbers: | 116740 |
| Study First Received: | May 31, 2012 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Atherosclerosis Cardiovascular Disease Acute coronary syndrome CV Risk |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013