Thomas J. Henry Investigating Alecardio Clinical Trials
San Antonio, Texas (July 17, 2013) A late stage trial for the Hoffmann-La Roche (Roche) experimental Type 2 Diabetes drug Aleglitazar was halted after an independent review board reportedly determined the drug could cause kidney and heart problems in patients and that the drug’s benefits did not outweigh risks.
Thomas J. Henry is currently screening cases from all over the country related to the Aleglitazar AleCardio clinical trials.
According to a statement by Roche[1] released on July 10, 2013, the Phase 3 clinical trial, known as the AleCardio trial, was halted on recommendation from the Data and Safety Monitoring Board (DSMB). According to a statement released by Roche, the board reportedly cited “safety signals and lack of efficacy.”
According to comments made by study chair Dr. Michael Lincoff (published in the New York Times [2] on July 10, 2013) and a statement by Roche spokesman Alexander Klauser (published in Businessweek [3] on July 10, 2013), injuries of concern include:
- Bone fractures
- Gastrointestinal bleeding
- Kidney damage
- Heart failure
Clinicaltrials.gov [4] states that the AleCardio trial involved 7,000 individuals worldwide, with trial locations in numerous countries including the United States. AleCardio trials took place at medical facilities in a number of U.S. states including:
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Illinois
- Indiana
- Iowa
- Kentucky
- Louisiana
- Maine
- Maryland
- Massachusetts
- MichiganAreas
- Minnesota
- Mississippi
- Montana
- Nebraska
- Nevada
- New Jersey
- New Mexico
- New York
- North Carolina
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- West Virginia
- Wisconsin
If you or a loved one participated in the AleCardio trial and suffered injuries, you are encouraged to contact an attorney immediately. Thomas J. Henry are available 24/7, night and day, at 1-888-956-8000 or thomasjhenrylaw.com.
Citations
1. https://www.roche.com/media/media_releases/med-cor-2013-07-10.htm
2. https://www.nytimes.com/2013/07/11/business/roche-abandons-new-diabetes-drug.html?_r=0
3. https://www.businessweek.com/news/2013-07-10/roche-halts-clinical-trials-of-diabetes-drug-on-safety-concern
4. https://clinicaltrials.gov/show/NCT01042769
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