HypertensionPhase 3NCT00435162
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
A Phase 3 study testing Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg and Valsartan 4.0 mg/kg in people with Hypertension, run by Novartis Pharmaceuticals at 11 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th… 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 0.25 mg/kg, Valsartan 1.0 mg/kg and Valsartan 4.0 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Mar 2007to Jan 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
- Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
- Must be able to swallow liquid formulation
- Must be ≥ 6 kg or ≤ 40 kg at randomization
- Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
- If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
- If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
- Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
Who cannot join
- Patients with background ARB therapy
- Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
- AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
- Glomerular filtration rate < 30 mL/min/1.73m²
- Serum potassium > upper limit of the reference range
- MSSBP ≥ 25% above the 95th percentile
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- Patients exhibiting clinically significant ECG abnormalities
- Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).
- Conditions
- Hypertension
- Being tested
- Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg, Valsartan 4.0 mg/kg
- 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.
Valsartan 0.25 mg/kgDrug
once daily
Valsartan 1.0 mg/kgDrug
once daily
Valsartan 4.0 mg/kgDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Not described Receives: Drug: Valsartan 0.25 mg/kg |
| Medium Dose | Experimental | Not described Receives: Drug: Valsartan 1.0 mg/kg |
| High Dose | Experimental | Not described Receives: Drug: Valsartan 4.0 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Measured: baseline and week 6
Secondary outcomes (3)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
Measured: baseline and week 6
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Measured: week 6 and week 8
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Measured: week 6 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionJan 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435162
- Sponsor's protocol ID
- CVAL489K2303
- Status last verified
- Apr 2011
- First submitted
- 13 Feb 2007
- Last updated
- 9 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.
- ClinicalTrials.gov ID
- NCT00435162
- Acronym / sponsor ID
- CVAL489K2303
- Conditions
- Hypertension
- Keywords
- Children, pediatrics, High Blood Pressure, Hypertension, Valsartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Posted 9 May 2011
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 safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Valsartan 0.25 mg/kg |
| Medium Dose | Experimental | Drug: Valsartan 1.0 mg/kg |
| High Dose | Experimental | Drug: Valsartan 4.0 mg/kg |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
- Must be able to swallow liquid formulation
- Must be ≥ 6 kg or ≤ 40 kg at randomization
- Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
- If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
Key exclusion criteria (9 listed)
- Patients with background ARB therapy
- Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
- AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
- Glomerular filtration rate < 30 mL/min/1.73m²
- Serum potassium > upper limit of the reference range
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 0.25 mg/kgonce daily | Drug | Low Dose |
| Valsartan 1.0 mg/kgonce daily | Drug | Medium Dose |
| Valsartan 4.0 mg/kgonce daily | Drug | High Dose |
Primary outcome
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Time frame: baseline and week 6
3 secondary outcomes
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
Time frame: baseline and week 6
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time frame: week 6 and week 8
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time frame: week 6 and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Sponsor GmbH
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg and Valsartan 4.0 mg/kg in people with Hypertension, run by Novartis Pharmaceuticals at 11 sites in 11 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 7 inclusion and 9 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 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Brazil, France, Hungary and 6 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 9 May 2011). 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 in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6) (time frame: baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2011.