HypertensionPhase 3NCT01365481
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
A Phase 3 study testing Valsartan, amlodipine and Hydrochlorothiazide in people with Hypertension and Chronic Kidney Disease, run by Novartis Pharmaceuticals at 28 sites in 10 countries.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- What is being tested?
- Valsartan, amlodipine and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 28 sitesin 10 countries
- Study dates
- Aug 2011to Sep 2015
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented diagnosis of hypertension
- able to swallow a tablet
- body weight ≥18 kg and ≤160 kg at baseline
- MSSBP must be ≥ 95th percentile and ≤25% above the 95th percentile for age, gender and height.
Who cannot join
- Any clinically significant physical abnormalities or clinically relevant abnormal laboratory values (other than those relating to renal function) obtained at the screening visit. Including the following:
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range. Patients known to have active or chronic hepatitis were excluded.
- Total bilirubin >2 times the upper limit of the reference range
- Estimated GFR <30 mL/min/1.73m² (calculated using Modified Schwartz Formula)
- WBC count <3000/mm³
- Platelet count <100,000/mm³
Show all 24Show fewer
- Serum potassium >5.3 mmol/L
- Hemoglobin <8 g/dL
- Uncontrolled diabetes mellitus
- Unilateral, bilateral and graft renal artery stenosis
- Current diagnosis of heart failure (New York Heart Association Class II-IV)
- Patients taking any of the following concomitant medications following screening: Renin-angiotensin receptor(RAAS) blockers other than study drug, Lithium, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels, Non-steroidal anti-inflammatory drugs (NSAIDS), including selective COX-2 inhibitors, acetylsalicylic acid >3g/day, and non-selective NSAIDs, Antidepressant drugs in the class of Monoamine oxidase (MAO) inhibitors (e.g. phenelzine), Chronic use of stimulant therapy for Attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD) -Patients who demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia and patients with second or third degree heart block without a pacemaker.
- Coarctation of the aorta with a gradient of >=30 mmHg
- Previous solid organ transplantation except renal transplantation.
- Patients known to be positive for the human immunodeficiency virus (HIV)
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
- Known or suspected contraindications to the study drug, including severe hepatic impairment, biliary cirrhosis, cholestasis and history of allergy to ARBs and/or angiotensin-converting enzymes (ACE) and/or Direct Renin Inhibitors (DRIs)
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Female patients of child-bearing potential, defined as all female patients physiologically capable of becoming pregnant, unless they are willing to use highly effective contraception during the study
- Pregnant or nursing (lactating) female patients
- Participation in any investigational drug study within 30 days prior to screening or within 5 elimination half-lives of the study drug prior to screening, or whichever is longer.
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
28 sites in 10 countries.
28 sites in 10 countries
Romania6 sites
Novartis Investigative Site
Bucharest, 041451
Novartis Investigative Site
Bucharest, 20395
Novartis Investigative Site
Cluj-Napoca, Jud Cluj
Novartis Investigative Site
Iași, 700309
Novartis Investigative Site
Tg. Mures, Jud Mures, 540104
Novartis Investigative Site
Timișoara, Jud. Timis, 300011
Germany5 sites
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Cottbus, 03048
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Rostock, 18107
Russia5 sites
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 119991
Novartis Investigative Site
Moscow, 125315
Novartis Investigative Site
Moscow, 127412
Novartis Investigative Site
Voronezh, 394036
Colombia3 sites
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bucaramanga, Santander Department, 0001
Novartis Investigative Site
Cali
Philippines3 sites
Novartis Investigative Site
Manila, Philippines, 1000
Novartis Investigative Site
Quezon City, Philippines, 1100
Novartis Investigative Site
Quezon City, Philippines, 1101
Singapore2 sites
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 229899
Guatemala1 site
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
About this study
Official title: A Multicenter, Open-label, 18 Month Study to Evaluate the Long-term Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age With Hypertension and With or Without Chronic Kidney Disease
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
- Conditions
- Hypertension, Chronic Kidney Disease
- Being tested
- Valsartan, amlodipine, Hydrochlorothiazide
- Keywords
- Hypertension, pediatric, Hypertension with or without chronic kidney disease
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Also called VAL489
week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily
amlodipineDrug
added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
HydrochlorothiazideDrug
Also called HCTZ
added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
| Study group | Role | What they receive |
|---|---|---|
| valsartan | Experimental | Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. Receives: Drug: Valsartan; Drug: amlodipine; Drug: Hydrochlorothiazide |
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) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Secondary outcomes (3)
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height
Measured: End Point (Week 78 or Last observation carried forward (LOCF)
Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline
Measured: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline
Measured: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2015
- Study completionSep 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT01365481
- Sponsor's protocol ID
- CVAL489K2305
- Other IDs
- 2009-017594-37, 2009
- Status last verified
- Jun 2016
- First submitted
- 9 May 2011
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, 18 Month Study to Evaluate the Long-term Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age With Hypertension and With or Without Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01365481
- Acronym / sponsor ID
- CVAL489K2305
- Conditions
- Hypertension, Chronic Kidney Disease
- Keywords
- Hypertension, pediatric, Hypertension with or without chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 21 Apr 2016
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 assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valsartan | Experimental | Drug: Valsartan, Drug: amlodipine, Drug: HydrochlorothiazideValsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Documented diagnosis of hypertension
- able to swallow a tablet
- body weight ≥18 kg and ≤160 kg at baseline
- MSSBP must be ≥ 95th percentile and ≤25% above the 95th percentile for age, gender and height.
Key exclusion criteria (24 listed)
- Any clinically significant physical abnormalities or clinically relevant abnormal laboratory values (other than those relating to renal function) obtained at the screening visit. Including the following:
- Uncontrolled diabetes mellitus
- Unilateral, bilateral and graft renal artery stenosis
- Current diagnosis of heart failure (New York Heart Association Class II-IV)
- Patients taking any of the following concomitant medications following screening: Renin-angiotensin receptor(RAAS) blockers other than study drug, Lithium, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels, Non-steroidal anti-inflammatory drugs (NSAIDS), including selective COX-2 inhibitors, acetylsalicylic acid >3g/day, and non-selective NSAIDs, Antidepressant drugs in the class of Monoamine oxidase (MAO) inhibitors (e.g. phenelzine), Chronic use of stimulant therapy for Attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD) -Patients who demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia and patients with second or third degree heart block without a pacemaker.
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 |
|---|---|---|
| ValsartanAlso: VAL489week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily | Drug | valsartan |
| amlodipineadded to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose | Drug | valsartan |
| HydrochlorothiazideAlso: HCTZadded to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose | Drug | valsartan |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
3 secondary outcomes
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
Time frame: End Point (Week 78 or Last observation carried forward (LOCF)
Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- 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
Novartis Pharmaceuticals
28 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, amlodipine and Hydrochlorothiazide in people with Hypertension and Chronic Kidney Disease, run by Novartis Pharmaceuticals at 28 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 4 inclusion and 24 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Romania, Germany, Russia, Colombia, Philippines 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 21 Apr 2016). 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) at End Point (Week 78 or Last Observation Carried Forward (LOCF) (time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)). The study lists 2 primary outcomes in all. 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 13 Jul 2016.