Screening for eligibility in the study of antihypertensive medication in children: experience from the Ziac Pediatric Hypertension Study.
BACKGROUND
The FDA Modernization Act has resulted in an increase in pediatric trials of antihypertensive medications. As experience is limited in children to guide the planning of these studies, we reviewed data from the Ziac Pediatric Hypertension Study to determine patterns of early study termination to help future studies.


METHODS
For inclusion, subjects aged 6 to 17 years were required to have an average systolic blood pressure (SBP) or diastolic blood pressure (DBP) above the 95th percentile at the last of three visits during 2 weeks of single-blind placebo screening. Early study termination was defined as early termination for any reason. Screening termination was defined as normalization of blood pressure (BP) during the placebo screening phase.


RESULTS
Early study termination rate was 27% (38 of 140 subjects). The most common reason was screening termination due to normalization of BP, accounting for 63% of all early study terminations. Among screening termination subjects who completed three screening visits, SBP was higher (P < .001) at visit 1 (129+/-8 mm Hg) than at visit 2 (123+/-7 mm Hg) or visit 3 (121+/-8 mm Hg), but did not differ between visits 2 and 3. Screening termination occurred in 15% with isolated SBP hypertension, and 21% with isolated DBP hypertension. At randomization, 83% had SBP hypertension and 53% had DBP hypertension.


CONCLUSIONS
These data suggest that SBP hypertension should be part of inclusion criteria to increase enrollment and reduce the rate of screening termination, and that 1-week placebo screening is necessary and sufficient to minimize inclusion of transiently hypertensive subjects.
Sorof
J M
JM
University of Texas-Houston, Medical School, 77030, USA. jsorof@ped1.med.uth.tmc.edu
Urbina
E M
EM
Cunningham
R J
RJ
Hogg
R J
RJ
Moxey-Mims
M
M
Eissa
M A
MA
Rolf
C
C
D000293:Adolescent; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D015924:Blood Pressure Monitors; D002648:Child; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008403:Mass Screening; D010352:Patient Dropouts; D018579:Patient Selection; D016037:Single-Blind Method
D000959:Antihypertensive Agents