Search Results - "Sager, Philip T"

Evolution of strategies to improve preclinical cardiac safety testing by Gintant, Gary, Sager, Philip T., Stockbridge, Norman

“…This article discusses evolving preclinical strategies for detecting drug-induced cardiotoxicity using human ion-channel assays, human-based in silico…”
Get full text

Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium by Sager, Philip T., MD, FACC, FAHA, Gintant, Gary, PhD, Turner, J. Rick, PhD, Pettit, Syril, MEM, Stockbridge, Norman, MD, PhD

“…This white paper provides a summary of a scientific proposal presented at a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/Food…”
Get full text

Novel oral anticoagulants and reversal agents: Considerations for clinical development by Sarich, Troy C., PhD, Seltzer, Jonathan H., MD, Berkowitz, Scott D., MD, Costin', James, MD, Curnutte, John T., MD, Gibson, C. Michael, MD, Hoffman, Maureane, MD, PhD, Kaminskas, Edvardas, MD, Krucoff, Mitchell W., MD, Levy, Jerrold H., MD, Mintz, Paul D., MD, Reilly, Paul A., PhD, Sager, Philip T., MD, Singer, Daniel E., MD, Stockbridge, Norman, MD, PhD, Weitz, Jeffrey I., DM, Kowey, Peter R., MD

“…This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank…”
Get full text

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting by Strauss, David G, Gintant, Gary, Li, Zhihua, Wu, Wendy, Blinova, Ksenia, Vicente, Jose, Turner, J Rick, Sager, Philip T

“…A Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA-sponsored Think Tank Meeting was convened in Washington, DC, on May…”
Get more information

Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block by Vicente, Jose, Johannesen, Lars, Hosseini, Meisam, Mason, Jay W, Sager, Philip T, Pueyo, Esther, Strauss, David G

“…Drugs that prolong the heart rate corrected QT interval (QTc) on the electrocardiogram (ECG) by blocking the hERG potassium channel and also block inward…”
Get full text

Clinical Evaluation of QT/QTc Prolongation and Proarrhythmic Potential for Nonantiarrhythmic Drugs: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 Guideline by Darpo, Borje, Nebout, Thierry, Sager, Philip T.

“…Proarrhythmias due to drug‐induced QT prolongation are the second most common cause for drug withdrawal and have caused increasing concern. Two new…”
Get full text

Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium by Sager, Philip T., MD, Seltzer, Jonathan, MD, Turner, J. Rick, PhD, Anderson, Jeffrey L., MD, Hiatt, William R., MD, Kowey, Peter, MD, Prochaska, Judith J., PhD, MPH, Stockbridge, Norman, MD, PhD, White, William B., MD

“…This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety…”
Get full text

Correction: Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block by Vicente, Jose, Johannesen, Lars, Hosseini, Meisam, Mason, Jay W, Sager, Philip T, Pueyo, Esther, Strauss, David G

“…[This corrects the article DOI: 10.1371/journal.pone.0163619.]…”
Get full text

The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development by Nada, Adel, MD, MS, MFPM, Gintant, Gary A., PhD, Kleiman, Robert, MD, Gutstein, David E., MD, Gottfridsson, Christer, MD, PhD, Michelson, Eric L., MD, Strnadova, Colette, PhD, Killeen, Matthew, MD, Geiger, Mary Jane, MD, PhD, Fiszman, Mónica L., MD, PhD, Koplowitz, Luana Pesco, MD, Carlson, Glenn F., MD, Rodriguez, Ignacio, MD, Sager, Philip T., MD

“…Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac…”
Get full text

Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: A report from the Cardiac Safety Research Consortium by Seltzer, Jonathan H., MD, MBA, MA, Turner, J. Rick, PhD, Geiger, Mary Jane, MD, PhD, Rosano, Giuseppe, MD, PhD, Mahaffey, Kenneth W., MD, White, William B., MD, Sabol, Mary Beth, MD, Stockbridge, Norman, MD, PhD, Sager, Philip T., MD

“…This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac…”
Get full text

Why translation from basic discoveries to clinical applications is so difficult for atrial fibrillation and possible approaches to improving it by Nattel, Stanley, Sager, Philip T, Hüser, Jörg, Heijman, Jordi, Dobrev, Dobromir

“…Abstract Atrial fibrillation (AF) is the most common sustained clinical arrhythmia, with a lifetime incidence of up to 37%, and is a major contributor to…”
Get full text

Electrocardiographic effects of class 1 selective histone deacetylase inhibitor romidepsin by Sager, Philip T., Balser, Barbara, Wolfson, Julie, Nichols, Jean, Pilot, Richard, Jones, Suzanne, Burris, Howard A.

“…Romidepsin is a histone deacetylase inhibitor approved by the FDA for the treatment of patients with cutaneous or peripheral T‐cell lymphoma who have received…”
Get full text

The Cardiac Safety Research Consortium Enters its Second Decade: An Invitation to Participate by Turner, J. Rick, PhD, Kowey, Peter R., MD, Rodriguez, Ignacio, MD, Cabell, Christopher H., MD, MHS, FACC, Gintant, Gary, PhD, Green, Cynthia L., PhD, Kunz, Barbara Lopez, MS, Mortara, Justin, PhD, Sager, Philip T., MD, FACC, Stockbridge, Norman, MD, PhD, Wright, Theressa J., MD, Finkle, John, MD, FACP, FACC, Krucoff, Mitchell W., MD, FACC, FAHA, FSCAI

“…Abstract The Cardiac Safety Research Consortium (CSRC), a transparent, public-private partnership established in 2005 as a Critical Path Program and formalized…”
Get full text

Response to Letter to the Editor by Blankfield regarding “Assessment of drug-induced increases in blood pressure during drug development: Report from the Cardiac Safety Research Consortium.” by White, William B., MD, FASH, FAHA, FACP, Sager, Philip T., MD, FACC

“…To the Editor: Dr Blankfield has raised 2 issues regarding our recent Cardiac Safety Research Consortium (CSRC) White Paper on assessing drug-induced blood…”
Get full text

Effect of Short-Term Rosuvastatin Treatment on Estimated Glomerular Filtration Rate by Vidt, Donald G., Harris, Susan, McTaggart, Fergus, Ditmarsch, Marc, Sager, Philip T., Sorof, Jonathan M.

“…To define the effect of short-term rosuvastatin treatment on the estimated glomerular filtration rate (eGFR), the database of controlled clinical trials in the…”
Get full text

Comparison of Effectiveness of Rosuvastatin Versus Atorvastatin on the Achievement of Combined C-Reactive Protein (<2 mg/L) and Low-Density Lipoprotein Cholesterol (<70 mg/dl) Targets in Patients With Type 2 Diabetes Mellitus (from the ANDROMEDA Study) by Betteridge, D. John, MD, PhD, Gibson, J. Martin, BSc, MD, PhD, Sager, Philip T., MD

“…Decreasing C-reactive protein (CRP) in addition to decreasing low-density lipoprotein (LDL) cholesterol may further decrease coronary heart disease risk. The…”
Get full text

Electrocardiographic assessment for therapeutic proteins—scientific discussion by Rodriguez, Ignacio, MD, Erdman, Andrew, MD, Padhi, Desmond, PharmD, Garnett, Christine E., PharmD, Zhao, Hong, PhD, Targum, Shari L., MD, Balakrishnan, Suchitra, MD, PhD, Strnadova, Colette, PhD, Viner, Norman, MD, Geiger, Mary Jane, MD, PhD, Newton-Cheh, Christopher, MD, MPH, Litwin, Jeffrey, MD, Pugsley, Michael K., PhD, Sager, Philip T., MD, Krucoff, Mitchell W., MD, Finkle, John K., MD

“…Electrocardiographic monitoring is an integral component of the clinical assessment of cardiac safety of all compounds in development. The International…”
Get full text

Cardiac imaging approaches to evaluate drug-induced myocardial dysfunction by Christian, Jennifer B., PharmD, MPH, PhD, Finkle, John K., MD, Ky, Bonnie, MD, Douglas, Pamela S., MD, Gutstein, David E., MD, Hockings, Paul D., PhD, Lainee, Pierre, DVM, PhD, Lenihan, Daniel J., MD, Mason, Jay W., MD, Sager, Philip T., MD, Todaro, Thomas G., MD, JD, Hicks, Karen A., MD, Kane, Robert C., MD, Ko, Hon-Sum, MD, Lindenfeld, JoAnn, MD, Michelson, Eric L., MD, Milligan, James, MB, ChB, Munley, Jiefen Y., MD, Raichlen, Joel S., MD, Shahlaee, Amir, MD, Strnadova, Colette, PhD, Ye, Brenda, MD, Turner, J. Rick, PhD

“…The ability to make informed benefit-risk assessments for potentially cardiotoxic new compounds is of considerable interest and importance at the public…”
Get full text

Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study by Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Ochoa‐Jimenez, Roberto, Mason, Jay W., Sanabria, Carlos, Kemp, Sarah, Sager, Philip T., Patel, Vikram, Matta, Murali K., Liu, Jiang, Florian, Jeffry, Garnett, Christine, Stockbridge, Norman, Strauss, David G.

“…Balanced multi‐ion channel‐blocking drugs have low torsade risk because they block inward currents. The Comprehensive In Vitro Proarrhythmia Assay (CiPA)…”
Get full text

Finding the Rhythm of Sudden Cardiac Death: New Opportunities Using Induced Pluripotent Stem Cell–Derived Cardiomyocytes by Sallam, Karim, Li, Yingxin, Sager, Philip T, Houser, Steven R, Wu, Joseph C

“…Sudden cardiac death is a common cause of death in patients with structural heart disease, genetic mutations, or acquired disorders affecting cardiac ion…”
Get full text