Drugs / ABT-335
ABT-335
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TRILIPIX | — | 2008-12-15 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03382756 | Oct → Nov 2017 | hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT03346187 | May 2017 | hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT00839293 | Feb → Mar 2009 | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00681525 | Apr → Jun 2008 | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00585143 | Jan → Oct 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00487136 | Jun → Jul 2007 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00673881 | Mar 2008 → May 2009 | hyperlipidemia | Radiant Research | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00680017 | Jun 2008 → Apr 2011 | chronic kidney disease, hyperlipidemia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00616772 | Feb 2008 → Sep 2012 | coronary artery disorder, hyperlipidemia | AbbVie | Completed | Missed primary |
| Phase 3 | NCT00491530 | Jun 2007 → Nov 2008 | hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05365425 | Jun 2023 → Dec 2026 expected | atherosclerosis, hyperlipidemia, type 2 diabetes mellitus | Seoul National University Bundang Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT00808678 Comparator | Dec 2008 → Jan 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00826358 Comparator | Nov 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00728780 Comparator | Aug → Sep 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00681395 Comparator | May → Aug 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00683176 Comparator | Sep 2008 → Mar 2011 | diabetic macular edema | Abbott Products | Completed | No outcome recorded |
| Phase 2 | NCT00728910 Comparator | Jun 2008 → Aug 2009 | hyperlipidemia | University of Pennsylvania | Completed | No outcome recorded |
| Phase 3 | NCT01030328 Comparator | Nov 2009 → Jul 2011 | coronary atherosclerosis | Piedmont Healthcare | Withdrawn | No outcome recorded |
| Phase 3 | NCT00639158 Comparator | Feb → Oct 2008 | coronary artery disorder, hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00463606 Comparator | Apr 2007 → Feb 2008 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00300469 Comparator | Mar 2006 → Feb 2007 | coronary artery disorder, hyperlipidemia, combined, 2 | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT01025492 Comparator | Nov 2009 → Mar 2011 | hyperlipidemia | University of Utah | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2009-06-04 | AstraZeneca | Regulatory AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia astrazeneca.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-06-04 | AstraZeneca | AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia astrazeneca.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABT-335 | “ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study” NCT00673881 ↗ |
| Known as | Choline fenofibrate | “CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)” NCT03346187 ↗4“Atorvastatin Calcium Trihydrate + Choline Fenofibrate” NCT03382756 ↗ |
| Known as | fenofibric acid | “coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium” NCT00808678 ↗2“fenofibric acid (ABT-335) + atorvastatin combination therapy” NCT00300469 ↗ “ABT-335 (Fenofibric Acid) 45 mg” NCT00826358 ↗ |
| Known as | Trilipix() | “In this multicenter, double-blind study, 682 patients were randomized to once-daily delayed-release capsules of choline fenofibrate 135 mg (fenofibric acid [Trilipix(®);...” PMID 22622962 ↗ Aug 2012 |
| Modality | Small molecule | “fibric acid derivative (fibrate) combination therapy” PMID 18783301 ↗ 2008 |
| Route | Oral | “ABT-335 135 mg monotherapy administered orally” NCT00463606 ↗ |