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Trial record 3 of 7 for:    aliskiren children

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

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ClinicalTrials.gov Identifier: NCT01151410
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Aliskiren
Drug: Enalapril
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aliskiren Enalapril
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 104 104
Safety Set (SAF) 105 103 [1]
Completed 93 89
Not Completed 11 15
Reason Not Completed
Withdrawal by Subject             3             5
Lost to Follow-up             3             4
Adverse Event             1             2
Protocol deviation             2             1
Administrative problems             1             1
Unsatisfactory therapeutic effect             1             1
Abnormal laboratory value(s)             0             1
[1]
Number of patients in SAF differed due to kit dispensing error in 1 patient at Visit 12
Arm/Group Title Aliskiren Enalapril Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 104 104 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 208 participants
11.7  (3.40) 11.9  (3.40) 11.8  (3.39)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
Children 6 – 11 years 50 51 101
Adolescents 12 – 17 years 54 53 107
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
Female
40
  38.5%
32
  30.8%
72
  34.6%
Male
64
  61.5%
72
  69.2%
136
  65.4%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study
Hide Description 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.
Time Frame Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients for this trial
Arm/Group Title Aliskiren Enalapril
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: millimeter(s) of mercury (mmHg)
-7.63  (1.16) -7.94  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren, Enalapril
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.31
Confidence Interval (1-Sided) 95%
-2.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Hide Description 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.
Time Frame Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients for this trial
Arm/Group Title Aliskiren Enalapril
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-3.90  (0.87) -4.94  (0.85)
3.Secondary Outcome
Title Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study
Hide Description 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).
Time Frame Baseline to end of study (Week 52 or LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients for this trial
Arm/Group Title Aliskiren Enalapril
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-5.15  (0.89) -5.95  (0.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Enalapril
Hide Arm/Group Description 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 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
All-Cause Mortality
Aliskiren Enalapril
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Enalapril
Affected / at Risk (%) Affected / at Risk (%)
Total   3/105 (2.86%)   12/103 (11.65%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/105 (0.00%)  1/103 (0.97%) 
Cardiac disorders     
Tachycardia  1  1/105 (0.95%)  0/103 (0.00%) 
Gastrointestinal disorders     
Paraesthesia oral  1  0/105 (0.00%)  1/103 (0.97%) 
General disorders     
Chest pain  1  1/105 (0.95%)  1/103 (0.97%) 
Device malfunction  1  0/105 (0.00%)  1/103 (0.97%) 
Infections and infestations     
Appendicitis  1  2/105 (1.90%)  1/103 (0.97%) 
Gastroenteritis  1  1/105 (0.95%)  0/103 (0.00%) 
Viral infection  1  0/105 (0.00%)  1/103 (0.97%) 
Injury, poisoning and procedural complications     
Concussion  1  0/105 (0.00%)  1/103 (0.97%) 
Dislocation of vertebra  1  0/105 (0.00%)  1/103 (0.97%) 
Head injury  1  0/105 (0.00%)  1/103 (0.97%) 
Skull fractured base  1  0/105 (0.00%)  1/103 (0.97%) 
Investigations     
Weight decreased  1  0/105 (0.00%)  1/103 (0.97%) 
Metabolism and nutrition disorders     
Tetany  1  0/105 (0.00%)  1/103 (0.97%) 
Nervous system disorders     
Headache  1  1/105 (0.95%)  0/103 (0.00%) 
Paraesthesia  1  0/105 (0.00%)  1/103 (0.97%) 
Psychiatric disorders     
Abnormal behaviour  1  0/105 (0.00%)  1/103 (0.97%) 
Psychosomatic disease  1  0/105 (0.00%)  1/103 (0.97%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/105 (0.00%)  1/103 (0.97%) 
Urethral stenosis  1  0/105 (0.00%)  1/103 (0.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren Enalapril
Affected / at Risk (%) Affected / at Risk (%)
Total   52/105 (49.52%)   51/103 (49.51%) 
Gastrointestinal disorders     
Vomiting  1  8/105 (7.62%)  5/103 (4.85%) 
General disorders     
Pyrexia  1  6/105 (5.71%)  5/103 (4.85%) 
Infections and infestations     
Bronchitis  1  5/105 (4.76%)  7/103 (6.80%) 
Nasopharyngitis  1  8/105 (7.62%)  6/103 (5.83%) 
Pharyngitis  1  7/105 (6.67%)  2/103 (1.94%) 
Upper respiratory tract infection  1  15/105 (14.29%)  15/103 (14.56%) 
Viral infection  1  10/105 (9.52%)  8/103 (7.77%) 
Nervous system disorders     
Headache  1  7/105 (6.67%)  15/103 (14.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/105 (7.62%)  9/103 (8.74%) 
Oropharyngeal pain  1  6/105 (5.71%)  7/103 (6.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 ­778 ­8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01151410     History of Changes
Other Study ID Numbers: CSPP100A2365E1
2009-017029-20 ( EudraCT Number )
First Submitted: June 23, 2010
First Posted: June 28, 2010
Results First Submitted: February 8, 2016
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016