Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age

NCT00244634 | Completed Phase 3

• 2 other identifiers: D2451C00261261A
• Study Type: interventional
• Target: 238
• Locations: 4 countries
• Sites: 44

Brief Summary

Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects. Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil or placebo. The study includes 2 panels based on subject weight. The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value. Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to \< 6 years of age.

Conditions

Pediatric Hypertension

Outcome Measures

Primary Outcomes (2)

• Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.

• The endpoint (outcome variable) is the slope by linear regression

Secondary Outcomes (7)

• To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.

• Determine the slope of the change from baseline to double-blind treatment in:

• • trough sitting diastolic blood pressure,

• • trough standing diastolic blood pressure and standing systolic blood pressure,

• • trough sitting pulse pressure.

Interventions

candsartan cilexetil DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female ages 6 to \< 17 years-of-age after parent or guardian's signing of informed consent.
• Subjects with hypertension that is either:
• Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
• Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
• Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
• A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).

You may not qualify if:

• 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.
• Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).
• Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
• Glomerular filtration rate \< 50 mL/min based on an estimated value using the Schwartz Formula.
• Nephrotic syndrome not in remission.
• Insulin dependent diabetes mellitus.
• Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.
• Clinically significant valvular heart disease.
• Clinical diagnosis of heart failure.
• Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).
• Second or third degree AV block.
• Pregnant or breast-feeding an infant.
• 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 AST or ALT.
• Known hypersensitivity to ARBs.
• Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (44)

Research Site

Beverly Hills, California, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Madera, California, United States

Location

Research Site

Yuba City, California, United States

Location

Research Site

Newark, Delaware, United States

Location

Research Site

Wilmington, Delaware, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Athens, Georgia, United States

Location

Research Site

Augusta, Georgia, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Park Ridge, Illinois, United States

Location

Research Site

Louisville, Kentucky, United States

Location

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

Jackson, Mississippi, United States

Location

Research Site

Port Gibson, Mississippi, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

Las Vegas, Nevada, United States

Location

Research Site

Paterson, New Jersey, United States

Location

Research Site

Brooklyn, New York, United States

Location

Research Site

New Hyde Park, New York, United States

Location

Research Site

The Bronx, New York, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Columbus, Ohio, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Pittsburgh, Pennsylvania, United States

Location

Research Site

Charleston, South Carolina, United States

Location

Research Site

Beaumont, Texas, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Charlottesville, Virginia, United States

Location

Research Site

Norfolk, Virginia, United States

Location

Research Site

Charleston, West Virginia, United States

Location

Research Site

Ghent, Belgium

Location

Research Site

Budapest, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Martin, Slovakia

Location

Research Site

Myjava, Slovakia

Location

Research Site

Trnava, Slovakia

Location

Study Officials

• AstraZeneca Atacand Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 2003
• Study Completion: November 1, 2005
• Last Updated: December 19, 2007

Record last verified: 2007-12

Locations

SL (4); BE (1); HU (3); US (36)