Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)

NCT00690612 | Completed Phase 3 Results DMC

• 1 other identifier: D2451C00006
• Study Type: interventional
• Target: 35
• Locations: 6 countries
• Sites: 13

Brief Summary

The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.

Conditions

Hypertension

Keywords

pediatric; renal disease; high blood pressure

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).

  Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.

  Every 3 months- baseline to final visit

• Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).

  Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.

  every 3 months - baseline to final visit

Study Arms (1)

1

EXPERIMENTAL

investigator determines efficacious dose based on child's BP response.

Drug: candesartan cilexetil

Interventions

candesartan cilexetil DRUG

0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose

Also known as: Atacand

1

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must have participated in Protocol 328 (without discontinuation due to a study drug related AE).
• Must sign an informed consent prior to initiating any stus dy procedures.
• Have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
• Weight ≥ 10 kg and ≤ 40 kg.

You may not qualify if:

• Any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
• 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) as determined at enrollment into Study 328.
• Impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
• Currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Edegem, Belgium, Belgium

Location

Research Site

Ghent, Belgium, Belgium

Location

Research Site

Strasbourg, France

Location

Research Site

Erlangen, Germany

Location

Research Site

Heidelberg, Germany

Location

Research Site

Marburg, Germany

Location

Research Site

Rostock, Germany

Location

Research Site

Genova, GE, Italy

Location

Research Site

Padua, PD, Italy

Location

Research Site

Gda�sk, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Crimea, Ukraine

Location

Research Site

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Hypertension; Kidney Diseases

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Franz Schaefer, MD

  University Children's Hospital, Heidelberg, Germany D69120

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 12, 2011
• Results First Posted: June 29, 2011

Record last verified: 2011-07

Locations

DE (4); BE (2); FR (1); UA (2); PL (2); IT (2)