A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00457626
• Collaborator: (none)
• Enrollment: 66
• Locations: 36
• Arm: 1
• Actual Duration (Months): 25.5
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Valsartan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension
• Actual Study Start Date: Apr 9, 2007
• Actual Primary Completion Date: May 25, 2009
• Actual Study Completion Date: May 25, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valsartan Open Label Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.	Drug: Valsartan; Extemporaneous suspension of valsartan, orally.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [Baseline to Week 26]

   Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.

2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [Baseline to Week 26]

   Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.

3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Week 8 to Week 26 of Extension Phase]

   An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Participants who qualified and entered the core study.

• Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.

Exclusion criteria

• Participants who did not complete Period 1 of the core study.

• Participants who were re-randomized in Period 2 of core study but did not continue for => 3 days in Period 2 of the core study.

• Participants who experienced any adverse events considered serious or drug related in the core study.

• Participants excluded from the core study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hackensack	New Jersey	United States	07601
2	Novartis Investigative Site	Philadelphia	Pennsylvania	United States	19104
3	Novartis Investigative Site	Norfolk	Virginia	United States	23510
4	Novartis Investigative Site	Antwerpen		Belgium	2020
5	Novartis Investigative Site	Edegem		Belgium	2650
6	Novartis Investigative Site	Gent		Belgium	9000
7	Novartis Investigative Site	Laeken		Belgium	1020
8	Novartis Investigative Site	Liege		Belgium	4000
9	Novartis Investigative Site	Goiania	GO	Brazil	74605-050
10	Novartis Investigative Site	Recife	PE	Brazil	50070-050
11	Novartis Investigative Site	Curitiba	PR	Brazil	80250-030
12	Novartis Investigative Site	Marseille		France	13385
13	Novartis Investigative Site	Paris Cedex 19		France	75935
14	Novartis Investigative Site	Toulouse		France	31026
15	Novartis Investigative Site	Budapest		Hungary	H-1083
16	Novartis Investigative Site	Szeged		Hungary	H-6720
17	Novartis Investigative Site	Hyderabad	Andh Prad	India	500033
18	Novartis Investigative Site	Mangalore	Karnataka	India	575001
19	Novartis Investigative Site	Indore	M.p.	India	425001
20	Novartis Investigative Site	Mumbai	Maharashtra	India	400026
21	Novartis Investigative Site	Chennai	Tamil Nadu	India	600008
22	Novartis Investigative Site	New Delhi		India	110 029
23	Novartis Investigative Site	Torino	TO	Italy	10126
24	Novartis Investigative Site	Palermo		Italy	90134
25	Novartis Investigative Site	Gdansk		Poland	80-952
26	Novartis Investigative Site	Krakow		Poland	30-663
27	Novartis Investigative Site	Lodz		Poland	93-338
28	Novartis Investigative Site	Poznan		Poland	60-572
29	Novartis Investigative Site	Szczecin		Poland	70-410
30	Novartis Investigative Site	Warszawa		Poland	04-730
31	Novartis Investigative Site	Gezina	Gauteng	South Africa	0084
32	Novartis Investigative Site	Cape Town		South Africa	7505
33	Novartis Investigative Site	Potchefstroom		South Africa
34	Novartis Investigative Site	Pretoria		South Africa	0002
35	Novartis Investigative Site	Ankara		Turkey	06100
36	Novartis Investigative Site	Izmir		Turkey	35040

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00457626
• Other Study ID Numbers: CVAL489K2303E1; 2006-005473-21
• First Posted: Apr 6, 2007
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan
• Additional relevant MeSH terms: Hypertension; Valsartan

Study Results

Participant Flow

Recruitment Details	The study was conducted at 35 investigative sites in 10 countries from 9 April 2007 to 25 March 2009.
Pre-assignment Detail	This study enrolled a total of 66 participants who completed the core study (NCT00435162).

Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
Period Title: Overall Study
STARTED	66
COMPLETED	60
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
Overall Participants	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.4 (1.41)
Sex: Female, Male (Count of Participants)
Female	23 34.8%
Male	43 65.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Description	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

The extension set (ESET) included all participants who entered the extension study, with administration of at least one dose of open-label study drug.

Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
Measure Participants	66
Baseline	114.7 (9.04)
Change from Baseline at Week 26	-11.2 (12.56)

2. Primary Outcome

Title	Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Description	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Time Frame	Baseline to Week 26

Outcome Measure Data

Analysis Population Description

The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.

Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
Measure Participants	66
Baseline	70.7 (11.14)
Change from Baseline at Week 26	-6.6 (11.84)

3. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Time Frame	Week 8 to Week 26 of Extension Phase

Outcome Measure Data

Analysis Population Description

The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.

Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
Measure Participants	66
AEs	38 57.6%
SAEs	4 6.1%

Adverse Events

Time Frame	Week 8 to Week 26 of Extension Phase
Adverse Event Reporting Description	The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
Arm/Group Title	Valsartan Open Label
Arm/Group Description	Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
All Cause Mortality
	Valsartan Open Label
	Affected / at Risk (%)	# Events
Total	0/66 (0%)
Serious Adverse Events
	Valsartan Open Label
	Affected / at Risk (%)	# Events
Total	4/66 (6.1%)
Infections and infestations
Viral infection	1/66 (1.5%)
Injury, poisoning and procedural complications
Contusion	1/66 (1.5%)
Head injury	1/66 (1.5%)
Wound	1/66 (1.5%)
Renal and urinary disorders
Nephrotic syndrome	1/66 (1.5%)
Other (Not Including Serious) Adverse Events
	Valsartan Open Label
	Affected / at Risk (%)	# Events
Total	38/66 (57.6%)
Gastrointestinal disorders
Diarrhoea	3/66 (4.5%)
Stomatitis	2/66 (3%)
Vomiting	3/66 (4.5%)
General disorders
Pyrexia	11/66 (16.7%)
Infections and infestations
Bronchitis	5/66 (7.6%)
Ear infection	3/66 (4.5%)
Nasopharyngitis	7/66 (10.6%)
Pharyngitis	3/66 (4.5%)
Rhinitis	3/66 (4.5%)
Tonsillitis	2/66 (3%)
Upper respiratory tract infection	5/66 (7.6%)
Urinary tract infection	2/66 (3%)
Varicella	2/66 (3%)
Viral infection	4/66 (6.1%)
Metabolism and nutrition disorders
Anorexia	2/66 (3%)
Nervous system disorders
Headache	3/66 (4.5%)
Respiratory, thoracic and mediastinal disorders
Cough	4/66 (6.1%)
Skin and subcutaneous tissue disorders
Urticaria	2/66 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 (i.e., data from all sites) in the clinical trial.