HypertensionPhase 3NCT00457626
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
A Phase 3 study testing Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 36 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 36 sitesin 10 countries
- Study dates
- 9 Apr 2007to 25 May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
India6 sites
Novartis Investigative Site
Chennai, Tamil Nadu, 600008
Novartis Investigative Site
Hyderabad, Andh Prad, 500033
Novartis Investigative Site
Indore, M.P., 425001
Novartis Investigative Site
Mangalore, Karnataka, 575001
Novartis Investigative Site
Mumbai, Maharashtra, 400026
Novartis Investigative Site
New Delhi, 110 029
Poland6 sites
Novartis Investigative Site
Gdansk, 80-952
Novartis Investigative Site
Krakow, 30-663
Novartis Investigative Site
Lodz, 93-338
Novartis Investigative Site
Poznan, 60-572
Novartis Investigative Site
Szczecin, 70-410
Novartis Investigative Site
Warsaw, 04-730
Belgium5 sites
Novartis Investigative Site
Antwerp, 2020
Novartis Investigative Site
Edegem, 2650
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Laken, 1020
Novartis Investigative Site
Liège, 4000
South Africa4 sites
Novartis Investigative Site
Cape Town, 7505
Novartis Investigative Site
Gezina, Gauteng, 0084
Novartis Investigative Site
Potchefstroom
Novartis Investigative Site
Pretoria, 0002
United States3 sites
Novartis Investigative Site
Hackensack, New Jersey, 07601
Novartis Investigative Site
Norfolk, Virginia, 23510
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Brazil3 sites
Novartis Investigative Site
Curitiba, Paraná, 80250-030
Novartis Investigative Site
Goiânia, Goiás, 74605-050
Novartis Investigative Site
Recife, Pernambuco, 50070-050
France3 sites
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Paris, 75935
Novartis Investigative Site
Toulouse, 31026
Hungary2 sites
Novartis Investigative Site
Budapest, H-1083
Novartis Investigative Site
Szeged, H-6720
Italy2 sites
Novartis Investigative Site
Palermo, 90134
Novartis Investigative Site
Torino, TO, 10126
Turkey (Türkiye)2 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Izmir, 35040
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- Valsartan
- Keywords
- Children, pediatrics, High Blood Pressure, Hypertension, Valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Extemporaneous suspension of valsartan, orally.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan Open Label | Experimental | 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. Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
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.
Measured: Baseline to Week 26
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
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.
Measured: Baseline to Week 26
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Week 8 to Week 26 of Extension Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study start9 Apr 2007
- Primary completion25 May 2009
- Study completion25 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457626
- Sponsor's protocol ID
- CVAL489K2303E1
- Other IDs
- 2006-005473-21
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2007
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.
PubMed 23511339
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00457626
- Acronym / sponsor ID
- CVAL489K2303E1
- Conditions
- Hypertension
- Keywords
- Children, pediatrics, High Blood Pressure, Hypertension, Valsartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2007 (actual)
- Primary completion
- 25 May 2009 (actual)
- Study completion
- 25 May 2009 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Posted 20 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valsartan Open Label | Experimental | Drug: ValsartanExtemporaneous 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValsartanExtemporaneous suspension of valsartan, orally. | Drug | Valsartan Open Label |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: 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.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23511339Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 36 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India, Poland, Belgium, South Africa, United States and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: Baseline to Week 26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.