A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 125

Inclusion Criteria

For study inclusion, subjects must fulfill all eligibility criteria

1) Signed informed consent by a parent or a legal guardian

2) Age 1 to less than 6 years

3) Weight =10 kg and = 40 kg

4) SiSBP and/or SiDBP = 95th percentile and = 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at screening and at randomization based on heightadjusted charts for age and gender (Appendices C through H). The blood pressure values that determine eligibility at screening and randomization are based on the average of three SiSBP measurements within a 7 mmHg range (consecutive or non-consecutive) in the arm with the higher BP measurement. Up to a maximum of six blood pressure measurements may be obtained to achieve the three SiSBP values within the 7 mmHg range.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following exclude subjects from study participation:

1) Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject’s participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints

2) Weight < 10 kg and > 40 kg

3) Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume

4) Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing’s syndrome

5) Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney

6) Estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 for non-transplant
patients and < 40 mL/min/1.73m2 for transplant patients based on the Schwartz Formula (Schwartz et al, 1987)

7) Renal transplant < 6 months prior to study entry

Subjects who have received a renal transplant = 6 months prior to study entry may
participate in the study if: 1) renal function is stable, 2) estimated GFR =40
mL/min/1.73m2, 3) stable doses of immunosuppressive medications are anticipated
throughout the 4-week, double-blind period of the study, 4) no episodes of acute allograft rejection have occurred within 30 days of study entry, and 5) the renal allograft has no documented renal artery stenosis

8) Nephrotic syndrome not in remission

9) Unstable insulin dependent diabetes mellitus

10) Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling

11) Clinically significant valvular heart disease

12) Clinical diagnosis of heart failure

13) Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms)

14) Second or third degree AV block

15) Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for aspartate aminotransferase (AST) or alanine aminotransferase (ALT)

16) Known hypersensitivity to ARBs

17) Currently receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor that in the investigator’s judgement cannot safely be withdrawn during the study

Subjects receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor may be eligible if they undergo withdrawal of the antihypertensive medication over a 2-week washout period and subsequently meet BP inclusion/exclusion criteria.

Subjects currently receiving other classes of antihypertensive medications (eg, diuretics, calcium channel blockers or beta-blockers) and whose BP values meet inclusion/exclusion criteria may participate in the study while continuing their current antihypertensive medication regimen. Up to 2 concomitant antihypertensive medications are permitted. Doses and dose regimens of concomitant antihypertensive medications must remain unchanged during the 4-week double-blind period of the study.

18) Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject

19) Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension

20) Received an investigational agent within 30 days prior to receiving study medicati

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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