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    Summary
    EudraCT Number:2006-005261-19
    Sponsor's Protocol Code Number:CVAL489K2303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-005261-19
    A.3Full title of the trial
    A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 1-5 years old with hypertension, followed by a 2 week placebo withdrawal period.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCVAL489K2303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namevalsartan
    D.3.2Product code VAL489K
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNValsartan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To evaluate a dose dependent reduction in MSSBP when comparing three doses of valsartan (0.25 mg,/kg, 1 mg/kg and 4 mg/kg ) over a 6 week period in children 1-5 years old with hypertension ( >= 95th percentile for age, gender, and height).
    E.2.2Secondary objectives of the trial
    Secondary objective(s): To evaluate the overall safety and tolerability of valsartan in 1 to 5 year old hypertensive children when treated for up to 6 weeks. To evaluate blood pressure change at the end of Period 2 from end of Period 1, when comparing pooled valsartan patients versus pooled placebo patients
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The investigator must ensure that all patients who meet all the inclusion criteria and none of the exclusion criteria are offered enrollment in the study. No additional exclusions can be applied by the investigator, in order that the study population will be representative of all eligible patients. 1. Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained. 2. Male or female between the ages of 1 to 5 years, at visit 1 with a documented history of hypertension. 3. Must be able to swallow the liquid formulation of the study medication 4. Must be >=8 kg or <= 40 kg 5. Patients, either naïve or treated, must have a documented history of a mean seated systolic blood pressure (mean of three measurements), equal to or greater than 95th percentile for age, gender and height (Appendix 3). 6. Patients with uncontrolled blood pressure, receiving background antihypertensive therapy, may continue on this therapy provided there is no change in dosing regimen. 7. Patient that has had a previous solid organ transplantation more than 1 year ago. Patient must be on stable doses of immunosuppressive therapy and deemed clinically stable by the clinician. Stable doses of immunosuppressive therapy are defined as no change in frequency or total daily doses of immunosuppressive therapy for at least 3 months prior to screening. Doses of immunosuppressive therapy must be maintained throughout Periods 1 and 2 of the study. 8. Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
    E.4Principal exclusion criteria
    Patients whose mean seated systolic blood pressure (mean of three measurements), at the baseline visit (Visit # 2) is >= 25% higher than the 95th percentile for age, gender and height see Appendix 3. 2. Physical examination of patient demonstrates abnormalities that would make this study medically hazardous to the patient. 3. Patients with background ARB therapy. 4. Patients that demonstrate any clinically significant abnormalities or clinically noteworthy abnormal laboratory values (other than those relating to renal function), including but not limited to the following: a. AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range b. Total bilirubin > 2 times the upper limit of the reference range c. Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR], see section 7.5.5 for formula, based on the serum creatinine concentration obtained at Visit 1 (Screening). d. WBC count < 3000/mm³ e. Platelet count < 100,000/mm³ f. Serum potassium > upper limit of the reference range 5. Patients that demonstrate clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and AV block controlled with a pacemaker. Examples of clinically significant ECG abnormalities considered exclusionary are as follows: a. Heart Rate out of Range i. Rate < 60 BPM ii. Rate > 165 BPM b. Arrhythmia c. Supraventricular Tachycardia d. Ventricular Tachycardia e. Atrial Tachycardia (Fibrillation, Flutter, etc.) f. Conduction Abnormality g. Complete Atrioventricular Block (without Pacemaker) h. Second Degree AV Block, Type II (without Pacemaker) i. Sinus Node Dysfunction (Pause > 3 seconds or Bradycardia <45BPM) j. Sick Sinus Syndrome k. Repolarization Abnormality l. Prolonged rate-corrected QT (QTc) interval > 460 ms m. Acute Ischemia or Infarction 6. Patients that have coarctation of the aorta with a gradient of >= 30 mm Hg, or renal artery stenosis 7. Patient that has any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication. 8. Patient that has experienced a significant clinical illness within 10 days prior to baseline visit. 9. Patient that is known to have tested positive for the hepatitis B surface antigen or hepatitis C antibody. 10. Patient that is known to have tested seropositive for the human immunodeficiency virus (HIV) or patient is concomitantly receiving anti-retroviral therapy. 11. Patient that has a clinically significant abnormality of the hepatic system, or a history of malabsorption or previous gastrointestinal surgery that could affect drug absorption or metabolism. 12. Patient that has a known sensitivity to valsartan or other angiotensin II receptor blockers (ARB). 13. Patient receiving any of the prohibited medications listed in protocol section 6.6.5 unless these medications may be withdrawn ethically, prior to visit 1. 14. Patient has taken an investigational drug within 30 days prior to study drug administration
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is: - Change from baseline in MSSBP (mean sitting systolic blood pressure) The primary analysis is for change from baseline at the Period I endpoint in a dose dependent manner. Baseline is defined as the Week 0 value. The Period I endpoint is defined as the Week 6 value or the last post-baseline observation during Period I carried forward (LOCF).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children 1 to 5 years old.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 75
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-21
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