Trial Outcomes & Findings for An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age (NCT NCT01151410)
NCT ID: NCT01151410
Last Updated: 2016-03-07
Results Overview
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
208 participants
Primary outcome timeframe
Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
Aliskiren
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
|
Overall Study
Safety Set (SAF)
|
105
|
103
|
|
Overall Study
COMPLETED
|
93
|
89
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
Aliskiren
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol deviation
|
2
|
1
|
|
Overall Study
Administrative problems
|
1
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
1
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
Baseline Characteristics
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Baseline characteristics by cohort
| Measure |
Aliskiren
n=104 Participants
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=104 Participants
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 3.40 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 3.40 • n=7 Participants
|
11.8 years
STANDARD_DEVIATION 3.39 • n=5 Participants
|
|
Age, Customized
Children 6 - 11 years
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Age, Customized
Adolescents 12 - 17 years
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)Population: Full analysis set (FAS) included all randomized patients for this trial
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Aliskiren
n=104 Participants
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=104 Participants
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study
|
-7.63 millimeter(s) of mercury (mmHg)
Standard Error 1.16
|
-7.94 millimeter(s) of mercury (mmHg)
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)Population: Full analysis set (FAS) included all randomized patients for this trial
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Aliskiren
n=104 Participants
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=104 Participants
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
|
-3.90 mmHg
Standard Error 0.87
|
-4.94 mmHg
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 52 or LOCF)Population: Full analysis set (FAS) included all randomized patients for this trial
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3\*(SBP--DBP).
Outcome measures
| Measure |
Aliskiren
n=104 Participants
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=104 Participants
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study
|
-5.15 mmHg
Standard Error 0.89
|
-5.95 mmHg
Standard Error 0.87
|
Adverse Events
Aliskiren
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Enalapril
Serious events: 12 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren
n=105 participants at risk
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=103 participants at risk
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/105
|
0.97%
1/103
|
|
Cardiac disorders
Tachycardia
|
0.95%
1/105
|
0.00%
0/103
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/105
|
0.97%
1/103
|
|
General disorders
Chest pain
|
0.95%
1/105
|
0.97%
1/103
|
|
General disorders
Device malfunction
|
0.00%
0/105
|
0.97%
1/103
|
|
Infections and infestations
Appendicitis
|
1.9%
2/105
|
0.97%
1/103
|
|
Infections and infestations
Gastroenteritis
|
0.95%
1/105
|
0.00%
0/103
|
|
Infections and infestations
Viral infection
|
0.00%
0/105
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/105
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/105
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/105
|
0.97%
1/103
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/105
|
0.97%
1/103
|
|
Investigations
Weight decreased
|
0.00%
0/105
|
0.97%
1/103
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/105
|
0.97%
1/103
|
|
Nervous system disorders
Headache
|
0.95%
1/105
|
0.00%
0/103
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/105
|
0.97%
1/103
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/105
|
0.97%
1/103
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/105
|
0.97%
1/103
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/105
|
0.97%
1/103
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/105
|
0.97%
1/103
|
Other adverse events
| Measure |
Aliskiren
n=105 participants at risk
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
|
Enalapril
n=103 participants at risk
Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.6%
8/105
|
4.9%
5/103
|
|
General disorders
Pyrexia
|
5.7%
6/105
|
4.9%
5/103
|
|
Infections and infestations
Bronchitis
|
4.8%
5/105
|
6.8%
7/103
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
8/105
|
5.8%
6/103
|
|
Infections and infestations
Pharyngitis
|
6.7%
7/105
|
1.9%
2/103
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
15/105
|
14.6%
15/103
|
|
Infections and infestations
Viral infection
|
9.5%
10/105
|
7.8%
8/103
|
|
Nervous system disorders
Headache
|
6.7%
7/105
|
14.6%
15/103
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
8/105
|
8.7%
9/103
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
6/105
|
6.8%
7/103
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 -778 -8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single- site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER