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candsartan cilexetil

Phase 3

Hypertension | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Dec 9, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment235

FDA Designations

No designations recorded

Clinical trial landscape

candsartan cilexetil · 2 trials · 2 indications

Phase 3 2
NCT00244595Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of AgeHypertension
COMPLETED235 Analytics
NCT00244634Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of AgePediatric Hypertension
COMPLETED238 Analytics
PHASE3COMPLETED
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
HypertensionUnlock trial analytics
PHASE3COMPLETED
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Pediatric HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

- Achieved sitting, trough, systolic blood pressure summarized over time and at Week 52 & the mean of the last two measures.
- The measure of effect is the mean value and the corresponding descriptive statistics.
- Additional measures include mean diastolic blood pressure, and the proportion of subjects meeting 'controlled' criteria.
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 Endpoints

- Subject and baseline characteristics, antecedent treatment (eg, in 261A, an double-blind placebo-controlled efficacy study that is described elsewhere)
- The relationship to efficacy measures
- The relationship of antihypertensive treatment (candesartan cilexetil dose; add on therapy) and achieved blood pressure.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
candsartan cilexetilDRUG -
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * The subjects must have fulfilled the eligibility criteria for and have participated in Study 261A or did not participate in Study 261A but meet the following criteria: * Diagnosed and untreated hypertension, or * Diagnosed and treated, but off antihypertensive treatment for at...

Countries:United StatesBelgiumHungarySlovakia
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Frequently asked questions about candsartan cilexetil

What is candesartan cilexetil used for?

Candesartan cilexetil is used for hypertension and pediatric hypertension. It is an investigational small molecule in Phase 3 development for these cardiovascular conditions. The drug is being studied in pediatric subjects aged 6 to less than 17 years with hypertension.

Who makes candesartan cilexetil?

Candesartan cilexetil is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetics in pediatric patients with hypertension.

What phase is candesartan cilexetil in?

Candesartan cilexetil is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for hypertension and pediatric hypertension. Two Phase 3 trials have been completed as part of its development program.

What clinical trials is candesartan cilexetil in?

Candesartan cilexetil has been studied in two completed Phase 3 trials: NCT00244595, which evaluated efficacy, safety, and pharmacokinetics in hypertensive pediatric subjects aged 6 to less than 17 years, and NCT00244634, a dose range finding study in pediatric subjects with hypertension.

Is candesartan cilexetil the same as Atacand?

Yes, candesartan cilexetil is the same as Atacand. One of its clinical trials, NCT00244634, is titled 'Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age,' confirming that Atacand is a brand name for candesartan cilexetil.