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ACE Inhibition

Phase 3

Children | Small molecule | Rare Disease |Baxter International Inc.|Last Updated: Jan 12, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

ACE Inhibition · 1 trial · 5 indications

Phase 3 1
NCT00221845Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric PatientsChildren
COMPLETED400 Analytics
PHASE3COMPLETED
Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients
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Study Endpoints

Primary Endpoints

Time interval to renal 'loss' as defined by an absolute decrease in creatinine clearance by 50 % or attainment of renal replacement therapy.
two-monthly

Secondary Endpoints

Effect of treatment on urinary protein excretion
two-monthly
Effect of treatment on blood pressure
two-monthly
Safety of treatment
initially weekly, than two-monthly
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Conventional BP ControlACTIVE_COMPARATORTargeted 24-hour mean arterial pressure will be the 50th-95th percentile for age.
Intensified BP ControlEXPERIMENTALTargeted 24-hour mean arterial pressure will be the 5th to 50th percentile for age.

Interventions

NameTypeDescription
ACE InhibitionDRUGACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
Intensified Blood Pressure ControlDRUGAny antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.
Add-on Angiotensin Receptor BlockadeDRUGIn patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.
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Eligibility Criteria

Age Range3 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Age 3-18 years * Moderate state of renal failure (creatinine clearance 15 - 75 ml / min / 1.73 m²) * Mean arterial blood pressure (ABPM) \> 50.percentile and/or antihypertensive treatment * Written informed consent Exclusion Criteria: * Age \<3 years or \>18 years at start o...

Countries:CzechiaFranceGermanyHungaryItalyLithuaniaPolandPortugalSerbiaSwedenSwitzerlandTurkey (Türkiye)
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Frequently asked questions about ACE Inhibition

What is ACE Inhibition used for in children?

ACE Inhibition is a small molecule being studied for use in children with chronic renal failure and hypertension, including acquired and congenital kidney disease. It is currently in Phase 3 clinical development and is being investigated as a treatment to slow the progression of chronic renal failure in pediatric patients.

What does ACE Inhibition target?

ACE Inhibition targets the angiotensin-converting enzyme (ACE), which plays a role in blood pressure regulation and kidney function. By inhibiting this enzyme, the drug aims to reduce blood pressure and potentially slow the progression of chronic renal failure in children with kidney disease.

Who makes ACE Inhibition?

ACE Inhibition is being developed by Baxter International Inc., a company publicly traded under the ticker symbol BAX. The company is conducting clinical research to evaluate the drug's safety and efficacy in pediatric patients with chronic renal failure and hypertension.

What phase is ACE Inhibition in?

ACE Inhibition is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for use. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.

What clinical trials is ACE Inhibition in?

ACE Inhibition has one completed Phase 3 clinical trial, identified as NCT00221845. This trial, titled 'Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients,' enrolled 400 children aged 3 years and older across multiple countries in Europe and Turkey.

Is ACE Inhibition the same as an ACE inhibitor?

Yes, ACE Inhibition refers to the class of drugs known as ACE inhibitors, which block the angiotensin-converting enzyme. In this context, it is the investigational treatment being studied by Baxter International for pediatric chronic renal failure and hypertension, though the specific drug name is not disclosed.