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Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01150357
First received: June 23, 2010
Last updated: September 15, 2015
Last verified: September 2015
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren (6.25/12.5/25 mg)
Drug: Aliskiren (37.5/75/150 mg)
Drug: Aliskiren (150/300/600 mg)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 51 centers in 8 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 334 participants were screened and placed in screening phase of single blind placebo washout period for up to a maximum of three weeks. Out of 334, 268 participants were randomized in Phase 1 including 1 mis-randomized participants who did not receive any medication. Therefore total of 267 was enrolled in this study

Reporting Groups
  Description
Aliskiren Low (6.25/12.5/25 mg)

During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.

During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment.

Aliskiren Mid (37.5/75/150 mg)

During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.

During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment.

Aliskiren High (150/300/600 mg)

During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.

During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment.


Participant Flow for 2 periods

Period 1:   Dose Response Phase (Phase 1)
    Aliskiren Low (6.25/12.5/25 mg)     Aliskiren Mid (37.5/75/150 mg)     Aliskiren High (150/300/600 mg)  
STARTED     108     54     105  
COMPLETED     107     51     102  
NOT COMPLETED     1     3     3  
Protocol Violation                 0                 1                 1  
Unsatisfactory therapeutic effect                 1                 0                 0  
Adverse Event                 0                 0                 1  
Withdrawal by Participants                 0                 2                 1  

Period 2:   Placebo-controlled Withdrawal (Phase 2)
    Aliskiren Low (6.25/12.5/25 mg)     Aliskiren Mid (37.5/75/150 mg)     Aliskiren High (150/300/600 mg)  
STARTED     107     51     102  
Started Aliskiren Treament     50     30     50  
Completed Aliskiren Treament     50     30     49  
Started Placebo Treatment     57     21     52  
Completed Placebo Treament     54     21     51  
COMPLETED     104     51     100  
NOT COMPLETED     3     0     2  
Adverse Event                 0                 0                 2  
Withdrawal by Subject                 2                 0                 0  
Lost to Follow-up                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed in the full analysis set population consisted of all participants who were randomized into the study.

Reporting Groups
  Description
Phase 1: Aliskiren Low (6.25/12.5/25 mg) Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
Phase 1: Aliskiren Mid (37.5/75/150 mg) Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
Phase 1: Aliskiren High (150/300/600 mg) Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
Total Total of all reporting groups

Baseline Measures
    Phase 1: Aliskiren Low (6.25/12.5/25 mg)     Phase 1: Aliskiren Mid (37.5/75/150 mg)     Phase 1: Aliskiren High (150/300/600 mg)     Total  
Number of Participants  
[units: participants]
  108     54     105     267  
Age  
[units: years]
Mean (Standard Deviation)
  11.9  (3.27)     11.6  (3.29)     11.8  (3.5)     11.8  (3.36)  
Age, Customized  
[units: participants]
       
Children 6 – 11 years     49     28     51     128  
Adolescents 12 – 17 years     59     26     54     139  
Gender  
[units: participants]
       
Female     35     17     39     91  
Male     73     37     66     176  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF)) ]

2.  Primary:   Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)   [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]

3.  Secondary:   Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)   [ Time Frame: Baseline up to Week 4 ]

4.  Secondary:   Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)   [ Time Frame: From Week 4 to Week 8 ]

5.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]

6.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)   [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]

7.  Secondary:   Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]

8.  Secondary:   Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)   [ Time Frame: Week 4 to endpoint (Week 8 or LOCF) ]

9.  Secondary:   Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]

10.  Secondary:   Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]

11.  Secondary:   Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)   [ Time Frame: Baseline to Week 4 ]

12.  Secondary:   Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]

13.  Secondary:   Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non-­Dipper Participants at Endpoint (Phase 1)   [ Time Frame: Baseline to endpoint (Week 4 or LOCF) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 ­778 ­8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01150357     History of Changes
Other Study ID Numbers: CSPP100A2365
2009-017028-22 ( EudraCT Number )
Study First Received: June 23, 2010
Results First Received: August 10, 2015
Last Updated: September 15, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
Turkey: General Directorate of Pharmaceuticals and Pharmacy
Hungary: National Institute of Pharmacy
Poland: The Central Register of Clinical Trials
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)