CompletedNCT01365481Updated Jul 13, 2016Results posted

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

A Phase 3 interventional study of Valsartan and amlodipine in Hypertension and Chronic Kidney Disease, sponsored by Novartis Pharmaceuticals. Completed at 28 sites in 10 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 150
Allocation: Not applicable
Ages: 6 Years to 17 Years
Sex: All

Study 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.

Conditions studied

Hypertension
Chronic Kidney Disease

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Keywords

Hypertension, pediatric
Hypertension with or without chronic kidney disease

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: 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

Exclusion Criteria:

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:
1. AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range. Patients known to have active or chronic hepatitis were excluded.
2. Total bilirubin >2 times the upper limit of the reference range
3. Estimated GFR \<30 mL/min/1.73m² (calculated using Modified Schwartz Formula)
4. WBC count \<3000/mm³
5. Platelet count \<100,000/mm³
6. Serum potassium >5.3 mmol/L
7. 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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 150 participants (actual)

Study arms

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.
Drug: Valsartan · Drug: amlodipine · Drug: Hydrochlorothiazide

Interventions

DrugValsartan
week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily
Also known as: VAL489
Drugamlodipine
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
DrugHydrochlorothiazide
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
Also known as: HCTZ

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

Secondary outcomes

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
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
Percentage of Patients with CKD who had Urine albumin creatinine reduction \>/= 50% from baseline
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
Percentage of Patients with CKD who had eGFR decrease \> 25 % from Baseline
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

Results

Posted Apr 21, 2016

Participant flow

A 1 arm study of valsartan but with 2 groups for analyses. The valsartan +antihypertensive group includes the patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

Participant flow — Overall Study
Milestone	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone
Started	23	52	18	57
Completed	16	37	14	50
Not completed	7	15	4	7
Withdrew: Adverse event	6	9	0	2
Withdrew: Withdrawal by subject	0	2	1	1
Withdrew: Lost to follow-up	1	1	2	3
Withdrew: Abnormal laboratory value(s)	0	1	0	0
Withdrew: Administrative problems	0	1	0	0
Withdrew: Protocol deviation	0	1	0	1
Withdrew: Unsatisfactory therapeutic effect	0	0	1	0

Outcome measures

PrimaryChange 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.

Time frame:: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Reported as:: Mean · millimeter(s) of mercury (mmHg)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
millimeter(s) of mercury (mmHg)	Valsartan + Antihypertensive Group	Valsartan Alone
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)	-13.3 ± 13.69	-15.5 ± 13.35

SecondaryNumber 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

Time frame:: End Point (Week 78 or Last observation carried forward (LOCF)
Reported as:: Number · Number of Participants

Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
Number of Participants	Valsartan + Antihypertensive Group	Valsartan Alone
MSSBP (n=39, 105)	23	90
MSDBP (n=28, 51)	20	47
MSSBP and MSDBP combined (n=40, 105)	22	88

SecondaryPercentage 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

Time frame:: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Reported as:: Number · Percentage of patients

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	Valsartan + Antihypertensive Group	Valsartan Alone
Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point	50.0 ± 404.08	41.9 ± 138.66

PrimaryChange 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.

Time frame:: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Reported as:: Mean · millimeter(s) of mercury (mmHg)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
millimeter(s) of mercury (mmHg)	Valsartan + Antihypertensive Group	Valsartan Alone
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)	-10.3 ± 11.94	-10.8 ± 11.45

SecondaryPercentage 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

Time frame:: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Reported as:: Number · Percentage of patients

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	Valsartan + Antihypertensive Group	Valsartan Alone
Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point	30.4 ± 404.08	27.5 ± 138.66

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Valsartan + Antihypertensive Group	—	8/41 (19.5%)	34/41 (82.9%)
Valsartan Alone	—	7/109 (6.4%)	68/109 (62.4%)
CKD Patients: Valsartan + Antihypertensive Group	—	7/23 (30.4%)	18/23 (78.3%)
CKD Patients: Valsartan Alone	—	4/52 (7.7%)	36/52 (69.2%)
Non-CKD Patients: Valsartan + Antihypertensive Group	—	1/18 (5.6%)	16/18 (88.9%)
Non-CKD Patients: Valsartan Alone	—	3/57 (5.3%)	32/57 (56.1%)

Most frequent serious events

Showing 10 of 21

Most frequent serious events
Event	Valsartan + Antihypertensive Group	Valsartan Alone	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone
Lupus nephritisRenal and urinary disorders	3/41	1/109	3/23	1/52	0/18	0/57
HypertensionVascular disorders	1/41	0/109	0/23	0/52	1/18	0/57
Febrile neutropeniaBlood and lymphatic system disorders	1/41	0/109	1/23	0/52	0/18	0/57
Oesophageal polypGastrointestinal disorders	1/41	0/109	1/23	0/52	0/18	0/57
Face oedemaGeneral disorders	1/41	0/109	1/23	0/52	0/18	0/57
Oedema peripheralGeneral disorders	1/41	0/109	1/23	0/52	0/18	0/57
GastroenteritisInfections and infestations	1/41	0/109	1/23	0/52	0/18	0/57
PneumoniaInfections and infestations	1/41	1/109	1/23	1/52	0/18	0/57
Glomerular filtration rate decreasedInvestigations	1/41	0/109	1/23	0/52	0/18	0/57
SynovitisMusculoskeletal and connective tissue disorders	1/41	0/109	1/23	0/52	0/18	0/57

Most frequent other events

Showing 10 of 46

Most frequent other events
Event	Valsartan + Antihypertensive Group	Valsartan Alone	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone
CoughRespiratory, thoracic and mediastinal disorders	18/41	18/109	12/23	12/52	6/18	6/57
PyrexiaGeneral disorders	12/41	18/109	8/23	12/52	4/18	6/57
HeadacheNervous system disorders	14/41	23/109	8/23	11/52	6/18	12/57
NasopharyngitisInfections and infestations	11/41	22/109	7/23	14/52	4/18	8/57
Upper respiratory tract infectionInfections and infestations	2/41	17/109	1/23	12/52	1/18	5/57
DizzinessNervous system disorders	8/41	17/109	4/23	6/52	4/18	11/57
VomitingGastrointestinal disorders	5/41	4/109	4/23	3/52	1/18	1/57
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	4/41	3/109	3/23	2/52	1/18	1/57
Abdominal painGastrointestinal disorders	4/41	7/109	2/23	4/52	2/18	3/57
InfluenzaInfections and infestations	3/41	1/109	1/23	0/52	2/18	1/57

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone	Total
Mean	12.90 ± 3.35	12.30 ± 3.20	13.79 ± 2.64	14.37 ± 2.83	13.36 ± 3.130

Age, Customized
Age, Customized(participants)	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone	Total
6 - 11 years	10	22	3	10	45
12 - 17 years	13	30	15	47	105

Sex: Female, Male
Sex: Female, Male(Participants)	CKD Patients: Valsartan + Antihypertensive Group	CKD Patients: Valsartan Alone	Non-CKD Patients: Valsartan + Antihypertensive Group	Non-CKD Patients: Valsartan Alone	Total
Female	12	16	3	20	51
Male	11	36	15	37	99

Study locations

28 sites

Novartis Investigative Site
Bucaramanga, Santander 0001, Colombia
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Helsinki, 00029, Finland
Novartis Investigative Site
Bochum, 44791, Germany
Novartis Investigative Site
Cottbus, 03048, Germany
Novartis Investigative Site
Freiburg, 79106, Germany
Novartis Investigative Site
Homburg, 66421, Germany
Novartis Investigative Site
Rostock, 18107, Germany
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Seoul, Korea 03080, Korea, Republic of
Novartis Investigative Site
Manila, 1000, Philippines
Novartis Investigative Site
Quezon City, 1100, Philippines
Novartis Investigative Site
Quezon City, 1101, Philippines
Novartis Investigative Site
Warszawa, 04-154, Poland
Novartis Investigative Site
Cluj-Napoca, Jud Cluj, Romania
Novartis Investigative Site
Tg. Mures, jud Mures 540104, Romania
Novartis Investigative Site
Timisoara, jud. Timis 300011, Romania
Novartis Investigative Site
Bucuresti, 041451, Romania
Novartis Investigative Site
Bucuresti, 20395, Romania
Novartis Investigative Site
Iasi, 700309, Romania
Novartis Investigative Site
Kazan, 420012, Russian Federation
Novartis Investigative Site
Moscow, 119991, Russian Federation
Novartis Investigative Site
Moscow, 125315, Russian Federation
Novartis Investigative Site
Moscow, 127412, Russian Federation
Novartis Investigative Site
Voronezh, 394036, Russian Federation
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Singapore, 229899, Singapore

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01365481
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 3, 2011
Start date: Aug 2011
Primary completion: Sep 2015
Completion: Sep 2015
Results posted: Apr 21, 2016
Last update: Jul 13, 2016

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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