HypertensionPhase 3NCT00446511
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
A Phase 3 study testing Valsartan and Enalapril in people with Hypertension, run by Novartis Pharmaceuticals at 9 sites in 9 countries.
Trial summary
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan and Enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Jun 2007to Jun 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302.
- Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP > 20%, but < 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
Who cannot join
- Renal artery stenosis.
- Current diagnosis of heart failure (NYHA Class II-IV).
- Second or third degree heart block without a pacemaker.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
- Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and AV block controlled with a pacemaker.
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- Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
- Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
About this study
Official title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
- Conditions
- Hypertension
- Being tested
- Valsartan, Enalapril, placebo matched to enalapril, placebo matched to valsartan
- Keywords
- children, pediatrics, high blood pressure, hypertension, valsartan, enalapril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
EnalaprilDrug
Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
placebo matched to enalaprilDrug
Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
placebo matched to valsartanDrug
placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients: Valsartan+enalapril | Experimental | Not described Receives: Drug: Valsartan; Drug: Enalapril |
| CKD patients: Enalapril | Active comparator | Not described Receives: Drug: Enalapril; Drug: placebo matched to valsartan |
| Non-CKD patients: Valsartan | Experimental | Not described Receives: Drug: Valsartan; Drug: placebo matched to enalapril |
| Non-CKD patients: Enalapril | Active comparator | Not described Receives: Drug: Enalapril; Drug: placebo matched to valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events
Measured: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
Secondary outcomes (4)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.
Measured: Core Baseline (Week 0) to Week 26
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
Measured: Week 26
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.
Measured: Core Baseline (Week 0) to Week 20
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.
Measured: Core Baseline (Week 0) to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446511
- Sponsor's protocol ID
- CVAL489K2302E1
- Status last verified
- Jun 2011
- First submitted
- 9 Mar 2007
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT00446511
- Acronym / sponsor ID
- CVAL489K2302E1
- Conditions
- Hypertension
- Keywords
- children, pediatrics, high blood pressure, hypertension, valsartan, enalapril
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Posted 6 Jun 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 extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD patients: Valsartan+enalapril | Experimental | Drug: Valsartan, Drug: Enalapril |
| CKD patients: Enalapril | Active comparator | Drug: Enalapril, Drug: placebo matched to valsartan |
| Non-CKD patients: Valsartan | Experimental | Drug: Valsartan, Drug: placebo matched to enalapril |
| Non-CKD patients: Enalapril | Active comparator | Drug: Enalapril, Drug: placebo matched to valsartan |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302.
- Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP > 20%, but < 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
Key exclusion criteria (9 listed)
- Renal artery stenosis.
- Current diagnosis of heart failure (NYHA Class II-IV).
- Second or third degree heart block without a pacemaker.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
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 |
|---|---|---|
| ValsartanValsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. | Drug | CKD patients: Valsartan+enalapril, Non-CKD patients: Valsartan |
| EnalaprilEnalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. | Drug | CKD patients: Enalapril, CKD patients: Valsartan+enalapril, Non-CKD patients: Enalapril |
| placebo matched to enalaprilPlacebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food. | Drug | Non-CKD patients: Valsartan |
| placebo matched to valsartanplacebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food. | Drug | CKD patients: Enalapril, Non-CKD patients: Enalapril |
Primary outcome
Number of Patients With Adverse Events
Time frame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
4 secondary outcomes
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26
Time frame: Core Baseline (Week 0) to Week 26
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
Time frame: Week 26
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
Time frame: Core Baseline (Week 0) to Week 20
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26
Time frame: Core Baseline (Week 0) to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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 chair
Novartis Pharmaceuticals
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valsartan and Enalapril in people with Hypertension, run by Novartis Pharmaceuticals at 9 sites in 9 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 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, France, Germany, Hungary and 4 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 6 Jun 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?
Number of Patients With Adverse Events (time frame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)). 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 12 Jul 2011.