Example of a phase IV trial involving several GPs and aiming at answering a scientific question: EOL;EXEMPLE D'UN ESSAI DE PHASE IV IMPLIQUANT DE NOMBREUX MEDECINS ET VISANT A REPONDRE A UNE QUESTION SCIENTIFIQUE: EOL

Therapie

Volumn 51, Issue 6, 1996, Pages 667-676

  Boissel, J P ^a   Meillard, O ^b   Perrin Fayolle, E ^c   Ducruet, T ^c   Alamercery, Y ^c   Sassano, P ^b   Benghozi, R ^b  

^a U de Pharmacologie Clinique   (France)

^b Laboratoires Sandoz   (France)

^c RCTs   (France)

Author keywords

Compliance; Hypertension; Multicentre study; Nicardipine; Slow release formulation

Indexed keywords

NICARDIPINE;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FORMULATION; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATIENT COMPLIANCE; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SLOW RELEASE FORMULATION;

ANTIHYPERTENSIVE AGENTS; COMPLIANCE; DRUG ADMINISTRATION SCHEDULE; FAMILY PRACTICE; FEMALE; HUMANS; MALE; MIDDLE AGED; NICARDIPINE; QUESTIONNAIRES;

EID: 0030455633     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (20)

1. Haynes RB, Taylor DW, Sackett DL. Compliance in health care. Baltimore: The Johns Hopkins University Press, 1979.
2. Urquhart J, Chevalley C. Impact of unrecognized dosing errors on the cost and effectiveness of pharmaceuticals. Drug Info J 1988; 22: 363-378.
3. Clinite JC, Kabat HF. Prescribed Drugs : Errors during self-administration. J Am Pharm Assoc 1969; 9: 450-452.
4. Cramer JA, Mattson RH, Prevey ML et al. How often is medication taken as prescribed? A novel assessment technique. JAMA 1989; 261: 3273-3277.
5. Cramer JA, Spilker B. Patient compliance in medical practice and clinical trials. New York: Raven Press, 1991.
6. Becker MH, Maiman LA. Strategies for enhancing patient compliance. J Community Health 1980; 6: 113-135.
7. Mullen PD, Green LW, Persinger GS. Clinical trials of patient education for chronic conditions: a comparative meta-analysis of intervention types. Prev Med 985; 14: 753-781.
8. Peck CL, King NJ. Increasing patient compliance with prescriptions. JAMA 1982; 248: 2874-2877.
9. Mermelstein LL, Hemo D. Medical admissions due to noncompliance with drug therapy. Int J Clin Pharm Ther Toxicol 1982; 20: 600-604.
10. Ayd FJ. Single daily dose of antidepressants. JAMA 1974; 230: 263-264.
11. Taggart AJ, Johnston GD, McDevitt DG. Does the frequency of daily dosage influence compliance with digoxin therapy? Br J Clin Pharmacol 1981; 1: 31-34.
12. Cockburn J, Reid L, Bowman JA, Sanson-Fisher RW. Effect of intervention on antibiotic compliance in patients in general practice. Med J Aust 1987; 147: 324-328.
13. Shulman N, Cutter G, Daugherty R et al. Correlates of attendance and compliance in the Hypertension Detection and Follow-up Program. Controlled Clinical Trials 1982; 3: 13-27.
14. Caldwell JR, Cobb S, Dowling MD, De Jongh D. The drop out problem in antihypertensive treatment: a pilot study of social and emotional factors influencing a patient ability to follow antihypertensive treatment. J Chron Dis 1970; 22: 579-592.
15. Lowenthal DT, Briggs WA, Mutterperl R et al. Patient compliance for antihypertensive medication: the usefulness of urine assays. Curr Ther Res 1976; 19: 405-409.
16. Burris JF, Weir MR, Opail S et al. An assessment of diltiazem and hydrochlorothiazide in hypertension; application of factorial trial design to a multicentre clinical trial of combination therapy. JAMA 1990; 263: 1507-1512.
17. Dubray C, Souchet T, Guerret M et al. Loxen® LP 50 mg. Document IV-A. 1.2. Etude comparative des profils cinétiques et pharmacologiques par rapport à une forme gélule de référence. Document d'expertise non publié, octobre 1986, Laboratoires Sandoz.
18. Boissel JP, Meillard O, Perrin-Fayolle E, Ducruet T, Alamercery Y, Sassano P, Benghozi R, on behalf of the EOL Research Group. Comparison between a BID and a TID regimen : improved compliance with no improved antihypertensive effect. Eur J Clin Pharmacol (accepté).
19. Taylor SH, Frais MA, Lee P et al. Anti-hypertensive dose-response effects of nicardipine in stable essential hypertension. Br J Clin Pharmacol 1985; 20: 135S-138S.
20. Alvan G., Hammarlund-Udenaes M., Odlind B. The validity of the sigmoid Emax model and efficiency concept in diuretic studies. Br J Clin Pharmacol 1991; 31: 210-211.