Clinical Study Report (CSR) Synopses
Our CSR synopses share the results of our clinical trials and the evidence we used to approve a new medicine or indication.
PhRMA Clinical Study Results Database
In October 2004, PhRMA created the Clinical Study Results Database to improve the transparency of clinical studies on new medicines. Since then, individual company and government databases have expanded dramatically, including the National Library of Medicine’s website. Due to the availability and extensive use of these databases, the PhRMA Clinical Study Results Database was phased out on December 20, 2011.
Our Approach to Posting CSR Synopses
We will post our CSR synopses for approved products and indications dating from May 2004 to AbbVie.com according to the following schedule.
For new products and indications that are approved after January 1, 2014—We will post CSR synopses within 18 months from the approval date for all AbbVie-sponsored clinical trials that are conducted in patients, regardless of the phase of the trial or the age of the study participants.
For products and indications that were approved prior to January 1, 2014—We are making CSR synopses available for trials dating from May 2004 and have taken a phased approach to posting CSR synopses for these historical trials :
For interventional clinical trials completed between May 2004 and September 2012, CSR synopses were posted by the end of 2015 for all AbbVie sponsored clinical trials that were conducted in patients, regardless of the phase of the trial or the age of the study participants.
For more recent interventional and observational clinical trials for approved products and indications completed since October 2012, we post CSR synopses within 18 months from the date that the last patient in the trial had his/her last study visit for all AbbVie-sponsored clinical trials that were conducted in patients, regardless of the phase of the trial or the age of the study participants.
List of products alphabetized by generic name
- Adalimumab – Humira
- Clarithromycin: Biaxin, Clacee, Klaricid, Klacid
- Divalproex Sodium: Depakote, Epival, Valcote
- Fenofibrate: TriCor, Lipanthyl, Lipantil
- Fenofibric Acid: Trilipix, Fibricor
- Glecaprevir/Pibrentasvir: Mavyret, Maviret
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP: Vicodin
- Leuprolide Acetate for Depot Suspension: Lupron
- Levodopa/Carbidopa: Duodopa
- Lopinavir/Ritonavir: Kaletra, Aluvia
- Niacin extended-release: Niaspan
- Niacin Extended-Release/Simvastatin: Simcor
- Ombitasvir, Paritaprevir and Ritonavir tablets, Dasabuvir tablets: Viekira Pak, Holkira Pak
- Palivizumab: Synagis
- Pancrelipase: CREON
- Paricalcitol: Zemplar
- Ritonavir: Norvir
- Sevoflurane: Sevoflurane, Sevorane, Ultane
- Sibutramine Hydrochloride: Meridia, Reductil
- Testosterone Gel: Androgel
- Trandolapril: Mavik, Gopten, Odrik
- Trandolapril/Verapamil: Tarka
- Venetoclax: Venclexta