Trial Outcomes & Findings for Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age (NCT NCT00244621)
NCT ID: NCT00244621
Last Updated: 2011-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
From randomisation to end of double-blind treatment (4 weeks)
Results posted on
2011-08-31
Participant Flow
The study population included male and female participants 1 to \<6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.
One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.
Participant milestones
| Measure |
Atacand .05 mg
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Double-blind Treatment Period
STARTED
|
29
|
32
|
32
|
|
Double-blind Treatment Period
COMPLETED
|
27
|
29
|
30
|
|
Double-blind Treatment Period
NOT COMPLETED
|
2
|
3
|
2
|
|
Open-label Treatment Period
STARTED
|
26
|
29
|
30
|
|
Open-label Treatment Period
COMPLETED
|
25
|
28
|
28
|
|
Open-label Treatment Period
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Atacand .05 mg
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Double-blind Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
0
|
1
|
0
|
|
Double-blind Treatment Period
Lack of Efficacy
|
0
|
1
|
0
|
|
Double-blind Treatment Period
Multiple Reasons
|
2
|
1
|
1
|
|
Open-label Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Open-label Treatment Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Open-label Treatment Period
Adverse Event
|
0
|
0
|
1
|
|
Open-label Treatment Period
Moved abroad
|
0
|
0
|
1
|
Baseline Characteristics
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
Baseline characteristics by cohort
| Measure |
Atacand .05 mg
n=29 Participants
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
1 to <2 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Customized
2 to <6 years
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomisation to end of double-blind treatment (4 weeks)Outcome measures
| Measure |
Atacand .05 mg
n=29 Participants
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)
|
-6.0 mm Hg
Standard Deviation 9.4
|
-8.9 mm Hg
Standard Deviation 9.2
|
-12.0 mm Hg
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: From randomisation to end of double-blind treatment (4 weeks)Outcome measures
| Measure |
Atacand .05 mg
n=29 Participants
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=32 Participants
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
|
-5.2 mm Hg
Standard Deviation 6.7
|
-7.9 mm Hg
Standard Deviation 12.9
|
-11.1 mm Hg
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: From randomisation to day 28Outcome measures
| Measure |
Atacand .05 mg
n=19 Participants
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=19 Participants
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=19 Participants
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
|
-11.1 Percent change
Interval -42.5 to 33.3
|
-40.6 Percent change
Interval -68.1 to 25.0
|
-50.0 Percent change
Interval -68.9 to 15.8
|
SECONDARY outcome
Timeframe: From randomisation to day 28Outcome measures
| Measure |
Atacand .05 mg
n=25 Participants
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=26 Participants
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=27 Participants
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
|
0.0 Percent change
Interval -25.0 to 50.0
|
-29.2 Percent change
Interval -50.0 to 0.0
|
0.0 Percent change
Interval -40.7 to 0.0
|
Adverse Events
Atacand .05 mg
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Atacand .20 mg
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Atacand .40 mg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atacand .05 mg
n=29 participants at risk
candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
|
Atacand .20 mg
n=32 participants at risk
candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
|
Atacand .40 mg
n=32 participants at risk
candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/32
|
|
Blood and lymphatic system disorders
Catheter Site Haematoma
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Blood and lymphatic system disorders
Catheter Site Necrosis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Blood and lymphatic system disorders
Pyrexia
|
0.00%
0/29
|
3.1%
1/32
|
3.1%
1/32
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/29
|
0.00%
0/32
|
3.1%
1/32
|
|
Infections and infestations
Bronchiolitis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Infections and infestations
External Ear Cellulitis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/32
|
|
Infections and infestations
Pyelonephritis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/32
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/29
|
6.2%
2/32
|
6.2%
2/32
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/32
|
|
Renal and urinary disorders
Glomerulonephritis Chronic
|
0.00%
0/29
|
0.00%
0/32
|
3.1%
1/32
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
|
Vascular disorders
Vena Cava Thrombosis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/32
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60