Effect of number of replicate electrocardiograms recorded at each time point in a thorough qt study on sample size and study cost

Journal of Clinical Pharmacology

Volumn 51, Issue 6, 2011, Pages 908-914

  Natekar, Mili ^a   Hingorani, Pooja ^a   Gupta, Pallavi ^a   Karnad, Dilip R ^a   Kothari, Snehal ^a   De Vries, Michiel ^b   Zumbrunnen, Troy ^b   Narula, Dhiraj ^a  

^a IQVIA   (United States)

^b Solvay Pharmaceuticals Inc   (Netherlands)

Author keywords

cardiac repolarization; cost benefit analysis; drug induced QT prolongation; electrocardiography; IKR channel

Indexed keywords

MOXIFLOXACIN; PLACEBO;

ADULT; ARTICLE; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG SAFETY; ELECTROCARDIOGRAM; FEMALE; HEART RATE; HEART REPOLARIZATION; HUMAN; MALE; NORMAL HUMAN; PHARMACODYNAMICS; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; RR INTERVAL; SAMPLE SIZE; SINGLE DRUG DOSE;

ACUTE TOXICITY TESTS; ADULT; AZA COMPOUNDS; COST-BENEFIT ANALYSIS; ELECTROCARDIOGRAPHY; FEMALE; HUMANS; MALE; MIDDLE AGED; QUINOLINES; SAMPLE SIZE;

EID: 79955858168     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010376962     Document Type: Article

References (12)

1. Darpo B, Nebout T, Sager PT. 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. J Clin Pharmacol. 2006 ; 46: 498-507
2. Malhotra BK, Glue P, Sweeney K, Anziano R, Mancuso J, Wicker P. Thorough QT study with recommended and supratherapeutic doses of tolterodine. Clin Pharmacol Ther. 2007 ; 81 (3). 377-385 (Pubitemid 46364489)
3. Zhang Lu, Chappell J, Gonzales CR, et al. QT effects of duloxetine at supratherapeutic doses: a placebo and positive controlled study. J Cardiovasc Pharmacol. 2007 ; 49: 146-153 (Pubitemid 46579948)
4. Malik M, Camm AJ. Evaluation of drug-induced QT interval prolongation: implications for drug approval and labelling. Drug Safety. 2001 ; 24: 323-351 (Pubitemid 32417533)
5. Agin MA, Kazierad DJ, Abel R, et al. Assessing QT variability in healthy volunteers. J Clin Pharmacol. 2003 ; 43: 1016-1040
6. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations. Drug Inf J. 2005 ; 39: 243-266
7. Salvi V, Karnad DR, Panicker GK, Kothari S. Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development. Br J Pharmacol. 2010 ; 159: 34-48
8. Tyl B, Kabbaj M, Fassi B, De Jode P, Wheeler W. Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: variability and sample size considerations. J Clin Pharmacol. 2009 ; 49: 905-915
9. Bloomfield DM, Kost JT, Ghosh K, et al. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther. 2008 ; 84: 475-480
10. Beasley CM, Mitchell MI, Dmitrienko AA, et al. The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval. J Am Coll Cardiol. 2005 ; 46: 678-687 (Pubitemid 41132697)
11. Malik M, Hnatkova K, Batchvarov V, Gang Y, Smetana P, Camm AJ. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. PACE. 2004 ; 27: 1659-1669 (Pubitemid 40041518)
12. Zhang L, Dmitrienko A, Luta G. Sample size calculations in thorough QT studies. J Biopharm Stat. 2008 ; 18: 468-482 (Pubitemid 351891686)