Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
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ClinicalTrials.gov Identifier: NCT01365481 |
Recruitment Status :
Completed
First Posted : June 3, 2011
Results First Posted : April 21, 2016
Last Update Posted : July 13, 2016
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Condition or disease | Intervention/treatment | Phase |
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Hypertension Chronic Kidney Disease | Drug: Valsartan Drug: amlodipine Drug: Hydrochlorothiazide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
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Experimental: valsartan
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.
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Drug: Valsartan
week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily
Other Name: VAL489 Drug: amlodipine 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 Drug: Hydrochlorothiazide 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
Other Name: HCTZ |
- 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.
- 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) ]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
- 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 Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline
- 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) ]Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
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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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365481
Colombia | |
Novartis Investigative Site | |
Bucaramanga, Santander, Colombia, 0001 | |
Novartis Investigative Site | |
Barranquilla, Colombia | |
Novartis Investigative Site | |
Cali, Colombia | |
Finland | |
Novartis Investigative Site | |
Helsinki, Finland, 00029 | |
Germany | |
Novartis Investigative Site | |
Bochum, Germany, 44791 | |
Novartis Investigative Site | |
Cottbus, Germany, 03048 | |
Novartis Investigative Site | |
Freiburg, Germany, 79106 | |
Novartis Investigative Site | |
Homburg, Germany, 66421 | |
Novartis Investigative Site | |
Rostock, Germany, 18107 | |
Guatemala | |
Novartis Investigative Site | |
Guatemala City, Guatemala, 01010 | |
Korea, Republic of | |
Novartis Investigative Site | |
Seoul, Korea, Korea, Republic of, 03080 | |
Philippines | |
Novartis Investigative Site | |
Manila, Philippines, 1000 | |
Novartis Investigative Site | |
Quezon City, Philippines, 1100 | |
Novartis Investigative Site | |
Quezon City, Philippines, 1101 | |
Poland | |
Novartis Investigative Site | |
Warszawa, Poland, 04-154 | |
Romania | |
Novartis Investigative Site | |
Cluj-Napoca, Jud Cluj, Romania | |
Novartis Investigative Site | |
Tg. Mures, jud Mures, Romania, 540104 | |
Novartis Investigative Site | |
Timisoara, jud. Timis, Romania, 300011 | |
Novartis Investigative Site | |
Bucuresti, Romania, 041451 | |
Novartis Investigative Site | |
Bucuresti, Romania, 20395 | |
Novartis Investigative Site | |
Iasi, Romania, 700309 | |
Russian Federation | |
Novartis Investigative Site | |
Kazan, Russian Federation, 420012 | |
Novartis Investigative Site | |
Moscow, Russian Federation, 119991 | |
Novartis Investigative Site | |
Moscow, Russian Federation, 125315 | |
Novartis Investigative Site | |
Moscow, Russian Federation, 127412 | |
Novartis Investigative Site | |
Voronezh, Russian Federation, 394036 | |
Singapore | |
Novartis Investigative Site | |
Singapore, Singapore, 119074 | |
Novartis Investigative Site | |
Singapore, Singapore, 229899 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01365481 History of Changes |
Other Study ID Numbers: |
CVAL489K2305 2009-017594-37 ( EudraCT Number ) |
First Posted: | June 3, 2011 Key Record Dates |
Results First Posted: | April 21, 2016 |
Last Update Posted: | July 13, 2016 |
Last Verified: | June 2016 |
Hypertension, pediatric Hypertension with or without chronic kidney disease |
Valsartan Hydrochlorothiazide Kidney Diseases Renal Insufficiency, Chronic Hypertension Vascular Diseases Cardiovascular Diseases Urologic Diseases Renal Insufficiency Amlodipine Antihypertensive Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors |