Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT02058641 | Feb → Aug 2014 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02000804 | Oct 2013 → Jan 2014 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01873339 | Jun → Sep 2013 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01852565 | May → Sep 2013 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01751074 | Dec 2012 → Mar 2013 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01711723 | Oct 2012 → Mar 2013 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01154114 | Jul → Oct 2010 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00743860 | Sep → Dec 2008 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00704431 | May → Oct 2008 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00622830 | Jan → Mar 2008 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00551317 | Jul → Sep 2007 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00411073 | Dec 2006 → ? | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00368576 | Aug 2006 → Oct 2007 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01506895 | Feb 2012 → Feb 2013 | diabetic macular edema | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00734032 | Aug 2008 → Jan 2009 | atherosclerosis | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00268996 | Nov 2005 → Aug 2007 | atherosclerosis | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT00269048 | Nov 2005 → Sep 2006 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01916720 | Jan → Jul 2003 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 33 trials · 2 missed | ||||||
| Phase 3 | NCT01067339 | Feb 2010 → Nov 2015 | — | Mayo Clinic | Completed | Missed primary |
| Phase 3 | NCT01000727 | Dec 2009 → Apr 2014 | acute coronary syndrome | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00799903 | Dec 2008 → Oct 2013 | atherosclerosis | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2014-05-13 | GlaxoSmithKline | Results GSK announces phase III study with darapladib did not meet primary endpoint in patients following an acute coronary syndrome gsk.com ↗
In the study, darapladib did not achieve the primary endpoint of a reduction of major coronary events versus placebo when added to standard of care. |
| 2014-03-30 | GlaxoSmithKline | Results GSK presents data from Phase III STABILITY study of darapladib in patients with chronic coronary heart disease gsk.com ↗
No difference was seen in the treatment groups in the time to first occurrence of MACE. |
| 2013-11-12 | GlaxoSmithKline | Results GSK announces top-line results from pivotal Phase III study of darapladib in chronic coronary heart disease gsk.com ↗
The study did not meet the primary endpoint measure, which was time to first occurrence of any major adverse cardiovascular event (MACE) from the composite of myocardial infarction (heart attack), stroke, and cardiovascular death (relative risk reduction of 6%; p=0.199). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-05-13 | GlaxoSmithKline | GSK announces phase III study with darapladib did not meet primary endpoint in patients following an acute coronary syndrome gsk.com ↗ |
| 2014-03-30 | GlaxoSmithKline | GSK presents data from Phase III STABILITY study of darapladib in patients with chronic coronary heart disease gsk.com ↗ |
| 2013-11-12 | GlaxoSmithKline | GSK announces top-line results from pivotal Phase III study of darapladib in chronic coronary heart disease gsk.com ↗ |
| 2009-12-09 | GlaxoSmithKline | GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib gsk.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darapladib | “BACKGROUND: The aim of this study was to assess the effects of darapladib, a selective oral investigational lipoprotein-associated phospholipase A2 inhibitor, on both plasma...” PMID 24586490 ↗ Feb 201417“This study examined the effects of darapladib, a selective lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) inhibitor, on biomarkers of cardiovascular (CV) risk.” PMID 18436114 ↗ Apr 2008 “SB-480848 (Darapladib)” NCT00622830 ↗ |
| Known as | SB-480848 | “Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by...” NCT01852565 ↗13“SB-480848 (darapladib) is a novel selective and orally active inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2) being developed by GlaxoSmithKline (GSK) for the...” NCT02000804 ↗ “A Study to Evaluate the Pharmacokinetics of the Enteric-Coated Micronized Free Base Formulation of Darapladib [SB-480848] and Its Metabolites in Healthy Volunteers.” NCT00743860 ↗ “Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy” NCT01916720 ↗ “A Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Doses of Darapladib (SB-480848) in Subjects With Severe Renal Impairment” NCT01711723 ↗ “An Open-label, Single-sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of Darapladib (SB-480848) in Healthy Subjects” NCT01873339 ↗ “The subjects will be administered 40 mg oral doses of darapladib (SB-480848) enteric-coated tablets daily for 10 consecutive days.” NCT01154114 ↗ “Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart” NCT00411073 ↗ “SB-480848 (darapladib)” NCT00704431 ↗ “Darapladib (SB480848)” NCT00551317 ↗ |
| Action | Inhibit | “Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor SB-480848” NCT00268996 ↗1“LDL-associated phospholipase A2 inhibitor” CHEMBL204021 ↗ |
| Modality | Small molecule | — CHEMBL204021 ↗ |
| Route | Oral | “Coronary heart disease (CHD) and CHD-risk equivalent patients (n = 959) receiving atorvastatin (20 or 80 mg) were randomized to oral darapladib 40 mg, 80 mg, 160 mg, or placebo...” PMID 18436114 ↗ Apr 2008 |
| Target | PLA2G7 | “LDL-associated phospholipase A2 inhibitor” CHEMBL204021 ↗ |