Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents (NCT NCT00389519)
NCT ID: NCT00389519
Last Updated: 2012-06-11
Results Overview
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
TERMINATED
PHASE3
422 participants
Baseline to 4 weeks
2012-06-11
Participant Flow
Study was conducted from October 2006 to November 2007 at 56 international sites
Subjects entered placebo run-in prior to randomization
Participant milestones
| Measure |
Placebo
|
Ramipril Low Dose
|
Ramipril Mid Dose
|
Ramipril High Dose
|
|---|---|---|---|---|
|
Placebo Run-In
STARTED
|
422
|
0
|
0
|
0
|
|
Placebo Run-In
COMPLETED
|
244
|
0
|
0
|
0
|
|
Placebo Run-In
NOT COMPLETED
|
178
|
0
|
0
|
0
|
|
Randomized
STARTED
|
83
|
41
|
40
|
80
|
|
Randomized
COMPLETED
|
81
|
41
|
40
|
80
|
|
Randomized
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Treated
STARTED
|
81
|
41
|
40
|
80
|
|
Treated
COMPLETED
|
79
|
40
|
40
|
76
|
|
Treated
NOT COMPLETED
|
2
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo
|
Ramipril Low Dose
|
Ramipril Mid Dose
|
Ramipril High Dose
|
|---|---|---|---|---|
|
Placebo Run-In
Did not meet blood pressure criteria
|
119
|
0
|
0
|
0
|
|
Placebo Run-In
Withdrawal by Subject
|
19
|
0
|
0
|
0
|
|
Placebo Run-In
Reason not specified
|
40
|
0
|
0
|
0
|
|
Randomized
Did not receive study drug
|
2
|
0
|
0
|
0
|
|
Treated
Adverse Event
|
1
|
0
|
0
|
2
|
|
Treated
Reason not specified
|
1
|
1
|
0
|
2
|
Baseline Characteristics
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
Baseline characteristics by cohort
| Measure |
Placebo
n=81 Participants
|
Ramipril Low Dose
n=41 Participants
|
Ramipril Mid Dose
n=40 Participants
|
Ramipril High Dose
n=80 Participants
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
12.2 years
STANDARD_DEVIATION 3.06 • n=5 Participants
|
12.3 years
STANDARD_DEVIATION 3.03 • n=7 Participants
|
12.1 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
12.3 years
STANDARD_DEVIATION 3.06 • n=4 Participants
|
12.2 years
STANDARD_DEVIATION 2.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
154 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
20 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
29 participants
n=4 Participants
|
84 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
25 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
20 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Outcome measures
| Measure |
Placebo
n=80 Participants
|
Ramipril Low Dose
n=41 Participants
|
Ramipril Mid Dose
n=40 Participants
|
Ramipril High Dose
n=80 Participants
|
|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure
|
-8.1 mm Hg
Standard Deviation 7.92
|
-9.7 mm Hg
Standard Deviation 10.68
|
-11.1 mm Hg
Standard Deviation 8.88
|
-11.3 mm Hg
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Outcome measures
| Measure |
Placebo
n=80 Participants
|
Ramipril Low Dose
n=41 Participants
|
Ramipril Mid Dose
n=40 Participants
|
Ramipril High Dose
n=80 Participants
|
|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure
|
-5.0 mm Hg
Standard Deviation 10.04
|
-5.8 mm Hg
Standard Deviation 10.17
|
-6.1 mm Hg
Standard Deviation 8.03
|
-8.4 mm Hg
Standard Deviation 9.14
|
SECONDARY outcome
Timeframe: Baseline up to 4 weeksPopulation: Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Value at end of treatment (up to 4 weeks) minus value at baseline
Outcome measures
| Measure |
Placebo
n=78 Participants
|
Ramipril Low Dose
n=39 Participants
|
Ramipril Mid Dose
n=38 Participants
|
Ramipril High Dose
n=77 Participants
|
|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Serum Creatinine
|
0.04 mg/dL
Standard Deviation 0.305
|
0.06 mg/dL
Standard Deviation 0.275
|
0.03 mg/dL
Standard Deviation 0.133
|
0.06 mg/dL
Standard Deviation 0.211
|
SECONDARY outcome
Timeframe: Baseline up to 4 weeksPopulation: Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Value at end of treatment (up to 4 weeks) minus value at baseline
Outcome measures
| Measure |
Placebo
n=79 Participants
|
Ramipril Low Dose
n=39 Participants
|
Ramipril Mid Dose
n=40 Participants
|
Ramipril High Dose
n=77 Participants
|
|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Serum Potassium
|
0.01 mg/dL
Standard Deviation 0.742
|
-0.20 mg/dL
Standard Deviation 0.475
|
-0.08 mg/dL
Standard Deviation 0.418
|
0.07 mg/dL
Standard Deviation 0.559
|
SECONDARY outcome
Timeframe: Baseline up to 4 weeksPopulation: Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
Outcome measures
| Measure |
Placebo
n=78 Participants
|
Ramipril Low Dose
n=39 Participants
|
Ramipril Mid Dose
n=38 Participants
|
Ramipril High Dose
n=77 Participants
|
|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)
|
-4.2 mL/min per 1.73 m2
Standard Deviation 27.85
|
-6.0 mL/min per 1.73 m2
Standard Deviation 24.74
|
-5.9 mL/min per 1.73 m2
Standard Deviation 26.29
|
-6.9 mL/min per 1.73 m2
Standard Deviation 30.58
|
Adverse Events
Placebo
Ramipril Low Dose
Ramipril Mid Dose
Ramipril High Dose
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
|
Ramipril Low Dose
n=41 participants at risk
|
Ramipril Mid Dose
n=40 participants at risk
|
Ramipril High Dose
n=80 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
pyelonephritis
|
0.00%
0/81
|
2.4%
1/41
|
0.00%
0/40
|
0.00%
0/80
|
|
Renal and urinary disorders
nephrotic syndrome
|
0.00%
0/81
|
0.00%
0/41
|
2.5%
1/40
|
0.00%
0/80
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
|
Ramipril Low Dose
n=41 participants at risk
|
Ramipril Mid Dose
n=40 participants at risk
|
Ramipril High Dose
n=80 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain upper
|
2.5%
2/81
|
0.00%
0/41
|
7.5%
3/40
|
1.2%
1/80
|
|
General disorders
chest pain
|
0.00%
0/81
|
0.00%
0/41
|
7.5%
3/40
|
0.00%
0/80
|
|
Infections and infestations
upper respiratory tract infection
|
2.5%
2/81
|
9.8%
4/41
|
2.5%
1/40
|
1.2%
1/80
|
|
Nervous system disorders
dizziness
|
2.5%
2/81
|
0.00%
0/41
|
5.0%
2/40
|
2.5%
2/80
|
|
Nervous system disorders
headache
|
7.4%
6/81
|
9.8%
4/41
|
7.5%
3/40
|
10.0%
8/80
|
Additional Information
Professional Information Services
King Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agreed not to individually publish results of the study. Investigators may participate in a joint multicenter publication of the study results. Written notice must be provided to King. King has the right to review the publication and can require deletion of Confidential Information and delay of publication to allow for filing of patent applications.
- Publication restrictions are in place
Restriction type: OTHER