Table I.

Anti-hypertensive studies and labeling changes following response to written request

Drug	Year Submitted	Class	Summary of Label Change	Trial	Study Type	Lower Age	Upper Age
CCB1	2001	Calcium channel blocker	Dose, PK information for ages 6–17 yrs ADVE profile in pediatric patients similar to that seen in adults	A B	Efficacy PK	6 yrs 6 mos	17 yrs 17 yrs
ACE1	2003	ACE inhibitor	Dose, PK information for ages 6–16 yrs Clearance higher and t-1/2 life less Not indicated for children < 6 yrs or GFR < 30 ml/min/1.73m^2 Suspension information provided	A B B C	PK, Eff PK PK PK (ts)	6 yrs 1 mo 1 mo 18 yrs	16 yrs 16 yrs 16 yrs 45 yrs
ACE2	2000 1999	ACE inhibitor	Labeling changes for age 1 mo to 16 yrs; Information on dose, efficacy and suspension preparation provided	A B C	Efficacy PK PK (ts)	6 yrs 1 mo 18 yrs	16 yrs 16 yrs 45 yrs
CCB2	2001	Calcium channel blocker	<Additional studies recommended>	A	Efficacy	6 yrs	12 yrs
ACE3	2002	ACE inhibitor	New dosing/pharmacokinetic data; New dosing for children > 50 kg	A B	Efficacy PK	6 yrs 1 mo	16 yrs 16 yrs
ARB1	1999 2004	Angiotensin II receptor blocker	Up to 4.5 mg/kg once daily not effective in lowering blood pressure in patients 6–16 yrs	A B C C	Efficacy PK PK (tt) PK (tt)	6 yrs 1 yrs 18 yrs 18 yrs	17 yrs 16 yrs 55 yrs 55 yrs
ACE4	2000	ACE inhibitor	Labeling change for children 6–16 yrs; Not recommended for pediatric patients < 6 yrs of GFR <30 ml/min/1.73m^2 Suspension information provided	A B C	Efficacy PK PK (ts)	6 yrs 1 mo 18 yrs	16 yrs 16 yrs 45 yrs
ARB2	2001	Angiotensin II receptor blocker	Labeling change for children 6–16 yrs; Not recommended for pediatric patients < 6 yrs of GFR <30 ml/min/1.73m^2 Suspension information provided	A B C	Efficacy PK PK (ts)	6 yrs 1 mo 18 yrs	16 yrs 16 yrs 45 yrs
ACE5	2001 2002	ACE inhibitor	<Additional studies recommended>	A B	Efficacy PK	5 yrs 1 mo	16 yrs 6 yrs

A: Safety, efficacy or tolerability studies, B: Pharmacokinetic studies, single or multiple doses, C: Bioequivalence or bioavailability studies.

PK, pharmacokinetic; ts, tablet versus suspension formulation; tt, coated versus small tablet formulation.