HypertensionPhase 3NCT00171041
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
A Phase 3 study testing valsartan in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan
- How many people
- 265 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2002to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 16 years
- All sexes
- Child
Who may be able to join
- CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
Who cannot join
- BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
- Other protocol-defined inclusion/exclusion criteria will also apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
E.Hanover, New Jersey, 07936
About this study
Official title: A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
- Conditions
- Hypertension
- Being tested
- valsartan
- Keywords
- PEDIATRIC HYPERTENSION, PEDIATRIC, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sitting systolic blood pressure after 2 weeks
Secondary outcomes (5)
Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change in diastolic blood pressure after 2 weeks to 4 weeks
Change from baseline diastolic blood pressure after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171041
- Sponsor's protocol ID
- CVAL489A2302
- Status last verified
- Nov 2016
- First submitted
- 10 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.
PubMed 21545397
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00171041
- Acronym / sponsor ID
- CVAL489A2302
- Conditions
- Hypertension
- Keywords
- PEDIATRIC HYPERTENSION, PEDIATRIC, VALSARTAN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
Key exclusion criteria (3 listed)
- BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
- Other protocol-defined inclusion/exclusion criteria will also apply.
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 |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
Change from baseline in sitting systolic blood pressure after 2 weeks
5 secondary outcomes
Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change in diastolic blood pressure after 2 weeks to 4 weeks
Change from baseline diastolic blood pressure after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 21545397Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.
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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
2 sites in 2 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 at 2 sites in 2 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 3 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 sitting systolic blood pressure after 2 weeks. 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 NCT00171041, 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 18 Nov 2016.