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. Author manuscript; available in PMC: 2012 Apr 23.
Published in final edited form as: Am Heart J. 2008 Oct;156(4):682–688. doi: 10.1016/j.ahj.2008.05.001

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.