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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365481
First received: May 9, 2011
Last updated: August 26, 2014
Last verified: August 2014

May 9, 2011
August 26, 2014
August 2011
September 2015   (final data collection date for primary outcome measure)
To assess the long-term safety and tolerability profile of valsartan in children with hypertension, with or without chronic kidney disease. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Adverse events will be summarized by primary system organ class and preferred terms, laboratory data will be summarized for change from baseline, for shift with respect to normal range, and for occurrence of abnormality as appropriate.
Same as current
Complete list of historical versions of study NCT01365481 on ClinicalTrials.gov Archive Site
  • Blood pressure reduction [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assess change from baseline in mean sitting systolic and mean sitting diastolic blood pressure.
  • Blood pressure control [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Mean sitting systolic and mean sitting diastolic blood pressure less than the 95th percentile for age, gender and height
  • Reduction in proteinuria and eGFR in patients with chronic kidney disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Urine albumin creatinine reduction >/= 50% from baseline estimated glomereular filtration rate (eGFR) reduction >/=25% from baseline
  • To assess the long-term efficacy of valsartan in reducing the mean sitting systolic (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in children with hypertension. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess the long-term efficacy of valsartan in controlling the MSSBP and MSDBP in children with hypertension. The target mean BP is <95th percentile for age, gender and height. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess the effect of valsartan and valsartan-based treatments on proteinuria and eGFR in a subset of children with hypertension and chronic kidney disease. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Chronic Kidney Disease
Drug: Valsartan
40/80/160 w2-78:80/160/320mg, oral, by mouth, once daily
Experimental: valsartan
Intervention: Drug: Valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
  • 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

Both
6 Years to 17 Years
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Argentina,   Colombia,   Finland,   Germany,   Guatemala,   India,   Korea, Republic of,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore
 
NCT01365481
CVAL489K2305, 2009-017594-37
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP