Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01365481
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : April 21, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 9, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE March 9, 2016
Results First Posted Date  ICMJE April 21, 2016
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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 ]
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.
Change History Complete list of historical versions of study NCT01365481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Valsartan
  • Drug: amlodipine
  • Drug: Hydrochlorothiazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Finland,   Germany,   Guatemala,   Korea, Republic of,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore
Removed Location Countries Argentina,   India
 
Administrative Information
NCT Number  ICMJE NCT01365481
Other Study ID Numbers  ICMJE CVAL489K2305
2009-017594-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2016

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