Drugs / Lipitor
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (9) | US (FDA) | LIPITOR | — | 1998-07-10 – 2017-06-23 | fda.gov ↗ |
| Approved | US (FDA) | LIPITOR | — | 1996-12-17 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02651753 | Jan → Mar 2016 | hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02819869 | Aug → Sep 2016 | hepatocellular carcinoma | Taipei Medical University WanFang Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 41 trial · 1 missed | ||||||
| Phase 4 | NCT03360916 | Feb 2018 → Jun 2024 | cardiovascular disorder | University of Kansas Medical Center | Completed | Missed primary |
| Phase not applicable2 trials | ||||||
| — | NCT00770679 | Jun 2008 → Jul 2012 | diabetes mellitus | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01305317 | Jan 2007 → Jan 2008 | chronic kidney disease | Hormozgan University of Medical Sciences | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT01455935 Comparator | Nov 2011 → Dec 2013 | stroke disorder | Jacobs Neurological Institute | Unknown | No outcome recorded |
| Phase 3 | NCT01710007 Comparator | Nov 2011 → Sep 2012 | hyperlipoproteinemia | Orient Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00532311 Comparator | Jul 2007 → Apr 2008 | hyperlipidemia | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00251680 Comparator | Oct 2005 → May 2007 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT01567826 Comparator | May 2010 → Feb 2012 | coronary artery disorder | Annapoorna Kini | Completed | Met primary |
| — | NCT00023231 Background | Feb 2001 → Aug 2004 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lipitor | “The experimental group take Lotidon 500mg/ tablet per day and Lipitor 10mg/ tablet per day for two years or until of a recurrence.” NCT02819869 ↗10“standard-care lipid-lowering therapy: Zocor or Lipitor” NCT01567826 ↗ “1. Lipitor 80 mg PO daily or” NCT01455935 ↗ “Lipitor” NCT00532311 ↗ |
| Known as | Atorvastatin calcium trihydrate | “Lipitor(Atorvastatin calcium trihydrate 21.70mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)” NCT02651753 ↗ |
| Route | Oral | “Oral tablet taken daily” NCT00023231 ↗ |