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

NCT ID: NCT01365481

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-09-30

Brief 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

Hypertension; Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Valsartan

Intervention Type: DRUG

week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily

amlodipine

Intervention Type: DRUG

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

Hydrochlorothiazide

Intervention Type: DRUG

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

Interventions

Valsartan

week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

VAL489; HCTZ

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Barranquilla, , Colombia

Novartis Investigative Site

Cali, , Colombia

Novartis Investigative Site

Helsinki, Finland, Finland

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Cottbus, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Novartis Investigative Site

Homburg, , Germany

Novartis Investigative Site

Rostock, , Germany

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, Guatemala

Novartis Investigative Site

Manila, Philippines, Philippines

Novartis Investigative Site

Quezon City, Philippines, Philippines

Novartis Investigative Site

Quezon City, Philippines, Philippines

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Cluj-Napoca, Jud Cluj, Romania

Novartis Investigative Site

Tg. Mures, Jud Mures, Romania

Novartis Investigative Site

Timișoara, Jud. Timis, Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Iași, , Romania

Novartis Investigative Site

Kazan', , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Voronezh, , Russia

Novartis Investigative Site

Singapore, Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore, Singapore

Novartis Investigative Site

Seoul, Korea, South Korea

Countries

Colombia; Finland; Germany; Guatemala; Philippines; Poland; Romania; Russia; Singapore; South Korea

Other Identifiers

2009-017594-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CVAL489K2305

Identifier Type: -

Identifier Source: org_study_id