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candsartan cilexetil

Phase 3

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

candsartan cilexetil development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Oct 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment473

FDA Designations

No designations recorded

candsartan cilexetil clinical trials

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
Hypertension
NCT00244595235
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PHASE3COMPLETED
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Pediatric Hypertension
NCT00244634238
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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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Competitive Landscape -Hypertension 72 trials

Top 9 of 16 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Baxdrostat
Eli Lilly and CompanyLLY4PHASE3Orforglipron, Clazakizumab
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484, HJB647
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
CRISPR Therapeutics AGCRSP1PHASE1CTX340
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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 a small molecule cardiovascular drug being developed by AstraZeneca PLC (AZN). It is currently in Phase 3 clinical development for these indications.

What does candesartan cilexetil target?

Candesartan cilexetil is an angiotensin II receptor blocker (ARB). It works by blocking the action of angiotensin II, a hormone that narrows blood vessels, which helps lower blood pressure.

Who makes candesartan cilexetil?

Candesartan cilexetil is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. The company is conducting Phase 3 clinical trials for this drug in hypertension and pediatric hypertension.

What phase is candesartan cilexetil in?

Candesartan cilexetil is in Phase 3 clinical development. It is an investigational drug for hypertension and pediatric hypertension, and it is not yet approved by the FDA.

What clinical trials is candesartan cilexetil in?

Candesartan cilexetil has been studied in two completed Phase 3 trials: NCT00244595, which evaluated its efficacy, safety, and pharmacokinetics in hypertensive pediatric subjects aged 6 to under 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. Atacand is a brand name for candesartan cilexetil, and it is being studied in pediatric hypertension trials.

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